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Recall Archives 21

FDA Recalls

July 1, 2007 -  December 30, 2007

 

 

 

 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 26, 2007:

CLASS II
MANUFACTURER: OrthoHelix Surgical Designs Inc, Akron, OH, by letter on Sept. 4, 2007. Firm initiated recall is ongoing
PRODUCT:
a) DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate;
b) Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24;
c) Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw cadies, Recall # Z-0136-2008
REASON: Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.

MANUFACTURER: Freedom Designs Inc, Simi Valley, CA, by letter on May 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Recall # Z-0137-2008
REASON: Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter and e-mail on September 4, 2007. Manufacturer: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, Size 6 X 12, MATL: Steel/Titanium, Rx only,
Recall # Z-0138-2008;
b) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, Size 6 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0139-2008;
c) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, Size 6 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0140-2008;
d) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, Size 7 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0141-2008;
e) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972267, Size 7 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0142-2008;
f) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, Size 7 X 18, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0143-2008
REASON: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

MANUFACTURER: Gen-Probe Inc, San Diego, CA, by telephone on May 2nd and 3rd, 2007 and by letter on May 3, 2007. Firm initiated recall is complete.
PRODUCT: Accuprobe Group B Streptococcus Culture Identification Test, Catalog number: 2820B, Batch number: 531379, Recall # Z-0145-2008
REASON: Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

MANUFACTURER: Encore Medical, Lp, Austin, TX, by telephone and letter on August 8, 2007. Firm initiated recall is complete.
PRODUCT: a) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert, Catalog #: 508-00-036, Sterile, Recall # Z-0184-2008;
b) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 40 RSP
Humeral Socket Insert, Catalog #: 508-00-040, Sterile, Recall # Z-0185-2008;
REASON: Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.

MANUFACTURER: Recalling Firm: Ellex USA, Eden Prairie, MN, by telephone on June 13, 2007 and by letters on September 27, 2007. Manufacturer: Ellex Medical Pty Ltd, Adelaide, SA Australia. Firm initiated recall is ongoing.
PRODUCT:
a) Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - DGS P/N 303896; Solitaire-SGS P/N 3038960, Recall # Z-0286-2008;
b) Ellex Integre Duo, Model No: LP1RG -S P/N 3040000. The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient
clinic, or a retinal specialist's office, Recall # Z-0287-2008
REASON: Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated September 11, 2007. Manufacturer: Danish Diagnostic Dev. A/S, Hrsholm, Denmark. Firm initiated recall is ongoing.
PRODUCT: C.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed), Model No: 9VIR1200, Recall # Z-0304-2008
REASON: Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 19, 2007:

CLASS II
MANUFACTURER: Recalling Firm: Global Protection Corp., Boston, MA, by e-mail on September 11, 2007. Manufacturer: Guilin Latex Factory, Guilin, Guangxi, China. Firm initiated recall is complete.
PRODUCT: Lubricated Latex Condom. Labeled in part: “Coming Together in DC”, Recall # Z-0054-2008
REASON: Condoms fail the water leak test and package integrity.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA, Inc, Memphis, TN, by letters on August 24, 2007. Manufacturer: Warsaw Orthopedic, Inc., dba Medtronic SOFAMOR DANEK, Warsaw, IN. Firm initiated recall is complete.
PRODUCT: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Recall # Z-0074-2008
REASON: Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cement Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
REASON: Mislabeled as to size. Labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

MANUFACTURER: VNUS Medical Technologies, Inc, CA, by letters on March 6, 2007. Firm initiated recall is complete.
PRODUCT: VNUS ClosureFAST catheters, Model number: CL7-7-100, Recall # Z-0132-2008
REASON: Sterility (package integrity) Compromised. Product sterility may be compromised due to a pinhole under the pouch foldover.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letters on September 17, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall $ Z-0146-2008;
b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall # Z-0147-2008
REASON: Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.
MANUFACTURER: Mizuho Orthopedic Systems, Inc., Union City, CA, by letter and telephone on February 28, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Recall # Z-0241-2008;
b) OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic
Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Recall # Z-0242-2008
REASON: Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter letters dated September 10, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare Advantage Workstations, Advantage Workstation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2, Recall # Z-0265-2008
REASON: Aortic Length over-estimated: Incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should not be used.

MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated June 30, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Recall # Z-0316-2008;
b) Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Recall # Z-0317-2008
REASON: Clip Detachment. The retainer c-clip can detach from the instrument during use and may fall into the surgical wound.

MANUFACTURER: Axya Medical, Beverly, MA, by letter dated September 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Axya Bone Anchor , 3.0 mm Titanium with Nylon Suture Catalog Number: CAT1226, Recall # Z-0331-2008;
b) Axya Bone Anchor, 5.0 mm Titanium with Nylon Suture Catalog Number: CAT1227, Recall # Z-0332-2008;
c) Axya Bone Anchor, 6.5 mm Titanium with Nylon Suture, Catalog Number: CAT1238, Recall # Z-0333-2008;
d) Axya Bone Anchor 3.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1268, Recall # Z-0334-2008;
e) Axya Bone Anchor 5.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1269, Recall # Z-0335-2008;
f) Axya Anchor, 5.0 mm Titanium in Super Kit, Catalog Number: CAT1270, Recall # Z-0336-2008;
g) Axya Bone Anchor 3.0 mm Titanium in Super Kit Catalog Number: CAT1274, Recall # Z-0337-2008;
h) Axya Bone Anchor, 3.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1230, Recall # Z-0338-2008;
i) Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Recall Z-0339-2008;
j) Axya Bone Anchor 6.5 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1264, Recall # Z-0340-2008;
k) Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Recall # Z-0341-2008;
l) Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1266, Recall # Z-0342-2008;
m) Axya Bone Anchor 5.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1267, Recall # Z-0343-2008;
n) Axya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Recall Z-0344-2008;
o) Axya Bone Anchor 3.0 mm Bioabsorbable in Super Kit Catalog Number: CAT1273, Recall # Z-0345-2008;
p) Arthocare 5mm ParaFix Anchor (5mm x 14.5mm) -2 strands of #2 braided suture, Part Number: 22-5001, Recall # Z-0346-2008;
q) Arthocare 3mm ParaFix Anchor (3mm x 9mm) -single strand of #2 braided suture,Part Number: 22-5002, Recall # Z-0347-2008;
r) Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Recall # Z-0348-2008;
s) Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Recall # Z-0349-2008;
t) Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5012, Recall # Z-0350-2008;
u) Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Recall Z-0351-2008;
v) Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055, Recall # Z-0352-2008;
w) Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number: 22-5055N, Recall # Z-0353-2008;
x) Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Recall # Z-0354-2008;
y) Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Recall # Z-0355-2008
REASON: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging.

MANUFACTURER: Recalling Firm: Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated November 2, 2007. Manufacturer: Stryker Medical Quebec, LP, L'Isletville, Canada. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker inTouch Critical Care bed; Model 2130, Recall # Z-0356-2008;
b) Stryker inTouch Zoom Critical Care bed, Model 2140, Recall # Z-0357-2008
REASON: Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated; 2) a battery charging defect which may result in a depletion of battery power; 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access; 4) beds equipped with zoom drive systems may have an overdrive problem which could result in the bed not being readily movable.

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on October 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Haemonetics cardioPAT System. Product list number 02050, (Cardiovascular Perioperative Autotransfusion), Recall # Z-0358-2008
REASON: Labeling (additional) use instructions to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient’s chest.

MANUFACTURER: Acist Medical Systems, Eden Prairie, MN, by letter on October 3 and 4, 2007, Firm initiated recall is ongoing.
PRODUCT: ACIST Multi-Use Syringe Kit, Model A2000; SKU #: 014612; labeled as STERILE; Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly), Recall # Z-0359-2008
REASON: Syringe Fracture: The syringe may be fractured, causing contrast to be sprayed from syringe fracture.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on November 13, 2006. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
PRODUCT: VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Recall # Z-0361-2008
REASON: Labeling Error: The VKS PE Ultra-congruent insert package may actually contain a Standard PE insert.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on Nov. 27, 2007 Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
PRODUCT: VKS Tibial Trial, Right/Left, Prep Guide, Recall # Z-0362-2008
REASON: The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.

MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by phone, e-mail and fax on April 30, 2007. Manufacturer: Blackstone Medical Inc., Springfield, MA. Firm initiated recall is complete.
PRODUCT: Ascent POCTS (Posterior Occipital Cervical Thoracic System). Recall # Z-0363-2008
REASON: Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a compromise of the integrity of the multi-axial locking mechanism.

MANUFACTURER: Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008
REASON: Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.

MANUFACTURER: Recalling Firm: Abbott Point of Care Inc., East Windsor, NJ.
Manufacturer: Abbott Point Of Care, Mississauga, Canada, Firm initiated recall is ongoing
PRODUCT:
a) Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct), Recall # Z-0370-2008
b) Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct), Recall # Z-0371-2008
c) Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct), Recall # Z-0372-2008
d) Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea), Recall # Z-0373-2008
e) Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct), Recall # Z-0374-2008
f) Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu), Recall # Z-0375-2008
REASON: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed

MANUFACTURER: Recalling Firm: Aesculap Implant Systems, Center Valley, PA, by letter dated Oct. 10, 2007. Manufacturer: Aesculap AG & Co. KG., Tuttlingen, Germany, Firm initiated recall is complete.
PRODUCT:
a) Excia Cemented Hip Stems, Size 9mm, Recall # Z-0436-2008;
b) Excia Cemented Hip Stems, Size 10mm, Recall # Z-0437-2008;
c) Excia Cemented Hip Stems, Size 11mm, Recall # Z-0438-2008;
d) Excia Cemented Hip Stems, Size 12mm, Recall # Z-0439-2008;
e) Excia Cemented Hip Stems, Size 13mm, Recall # Z-0440-2008;
f) Excia Cemented Hip Stems, Size 14mm, Recall # Z-0441-2008;
g) Excia Cemented Hip Stems, Size 15mm, Recall # Z-0442-2008;
h) Excia Cemented Hip Stems, Size 16mm, Recall # Z-0443-2008;
i) Excia Cemented Hip Stems, Size 17mm, Recall # Z-0444-2008;
j) Excia Cemented Hip Stems, Size 18mm, Recall # Z-0445-2008
REASON: Sterility (package integrity) Compromised: Device package damaged during shipment.

MANUFACTURER: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letter on September 19, 2006. Firm initiated recall is complete.
PRODUCT:
a) Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Recall # Z-0448-2008;
b) Triathlon MIS Femoral Adjustment Block; Catalog Number: 6541-5-601, Recall # Z-0449-2008;
c) Triathlon MIS Modular Capture; Catalog Number: 6541-5-723, Recall # Z-0450-2008
REASON: Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated November 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008
REASON: Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group

MANUFACTURER: Recalling Firm: ConMed Electrosurgery, Centennial, CO, by letter on November 2, 2007. Manufacture: ConMed Corporation, Utica, NY. Firm initiated recall is ongoing.
PRODUCT: Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers: 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Recall # Z-0452-2008
REASON: Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal.

MANUFACTURER: Becton Dickinson and Company, Waltham, MA, by letter and telephone on November 20, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in), Sterile, Catalog #/REF #: 585155, Recall Z-0453-2008;
b) BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Recall # Z-0454-2008
REASON: No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated August 30, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **,LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732, Recall # Z-0459-2008
REASON: False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 28, 2007. Manufacturer: Benoist, Herouville, St Clair, France. Firm initiated recall is ongoing.
PRODUCT:
a) Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm; Sterile; IMPLANT SIZE 1, Recall # Z-0463-2008;
b) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-002, IMPLANT SIZE 2, Sterile, Recall # Z-0464-2008;
c) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-003, IMPLANT SIZE 3, Sterile; Recall # Z-0465-2008;
d) Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-004, IMPLANT SIZE 4, Sterile; Recall # Z-0466-2008;
e) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Recall # Z-0467-2008;
f) Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Recall # Z-0468-2008;
g) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-007, IMPLANT SIZE 7, Recall # Z-0469-2008;
h) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8, Recall # Z-0470-2008;
i) V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Recall # Z-0471-2008;
j) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-010, IMPLANT SIZE 10, Recall # Z-0472-2008;
k) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Recall # Z-0473-2008;
l) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-012, IMPLANT SIZE 12, Recall # Z-0474-2008
REASON: Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated October 17, 2007. Manufacturer: Benoist, Herouville St Clair, France. Firm initiated recall is ongoing.
PRODUCT: Hipstar TMZF Cementless Hip Stem Protocol, Product number: LSP60, Recall # Z-0475-2008
REASON: Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of + 12 should have been omitted.

CLASS III
MANUFACTURER: Arkray USA, Inc., Minneapolis, MN, by letter on October 18, 2007 and October 26, 2007. Firm initiated recall is ongoing.
PRODUCT: Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Coding chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide), Recall # Z-0458-2008
REASON: Mis-labeled/coded strips: Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter will function properly and give accurate results if the "687" code chip and "867" test strips are used together. However to minimize possibility for confusion or inconvenience by the end user, ARKRAY has decided to recall the product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 12, 2007:

CLASS II
MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
REASON: Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

MANUFACTURER: Recalling Firm: Arjo, Inc. Roselle IL, by letter on October 15, 2007. Manufacturer: Arjo Hospital Equipment, Esloev, Sweden. Firm initiated recall is ongoing.
PRODUCT: Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift, Recall # Z-0261-2008
REASON: Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.

MANUFACTURER: Recalling Firm: Straumann USA LLC, Andover, MA, by letters on September 28, 2007 Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Straumann Palatal Implant, 04.1 L 4.2 mm, Article Number: 042.335S,
Recall # Z-0277-2008; b) Straumann Palatal Implant, 4.8 L 4.2 mm, Article Number: 042.336S, Recall # Z-0278-2008
REASON: Sticking Transfer Piece. The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Recall # Z-0321-2008;
b) Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Recall # Z-0322-2008
REASON: Failure to Operate: The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number: 801046, Recall # Z-0323-2008
REASON: Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.

MANUFACTURER: Boston Scientific Corp, Spencer, IN, by letter on July 19, 2007. Firm initiated recall is complete.
PRODUCT: Boston Scientific Accustick II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF, Recall # Z-0328-2008
REASON: Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Bothell, WA, by letter dated September 21, 2007. Manufacturer: Philips Medical Systems Netherlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Allura Xper FD20 X-Ray System, Release 2.2, Recall # Z-0329-2008;
b) Allura Xper FD20/10, Release 1.2, Recall # Z-0330-2008
REASON: Inaccurate anatomical measurements when using the optional SmartMask feature.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated December 6, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High Energy Medical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0380-2008;
b) Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners,
Recall # Z-0381-2008;
c) Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0382-2008;
d) Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
Recall Z-0383-2008;
e) Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
Recall Z-0384-2008
REASON: Products collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

MANUFACTURER: Depuy Orthopedics, Inc., Warsaw, IN, by letters dated September 27, 2007. Firm initiated recall is ongoing.
PRODUCT:
1) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430, Recall # Z-0385-2008;
2) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431,
Recall # Z-0386-2008;
3) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432;
Recall # Z-0387-2008;
4) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433,
Recall # Z-0388-2008;
5) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440,
Recall # Z-0389-2008;
6) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441,
Recall # Z-0390-2008;
7) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442,
Recall # Z-0391-2008;
8) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451, Recall # Z-0392-
2008;
9) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452,
Recall # Z-0393-2008;
10) Depuy P.F.C. ® E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453,
Recall # Z-0394-2008;
11) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471,
Recall # Z-0395-2008;
12) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521,
Recall # Z-0396-2008;
13) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522,
Recall # Z-0397-2008;
14) Depuy P.F.C. ® E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product
Code/REF 96-0523, Recall # Z-0398-2008;
15) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527,
Recall # Z-0399-2008;
16) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544, Recall # Z-0400-
2008;
17) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551, Recall # Z-0401-
2008;
18) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630,
Recall # Z-0402-2008;
19) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640,
Recall # Z-0403-2008;
20) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641,
Recall # Z-0404-2008;
21) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650,
Recall # Z-0405-2008;
22) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651,
Recall # Z-0406-2008;
23) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF
96-0663, Recall # Z-0407-2008;
24) Depuy P.F.C. ® E RP Knee System Rotating Platform Curved Tibial Insert (RP-CVD), 10mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2041,
Recall # Z-0408-2008;
25) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5mm, Size 2.5, UHMWPE, sterile; Product Code/REF 96-2122,
Recall # Z-0409-2008;
26) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2131,
Recall # Z-0410-2008;
27) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132,
Recall # Z-0411-2008;
28) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 15 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2133,
Recall # Z-0412-2008;
29) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2134,
Recall # Z-0413-2008;
30) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert(RP-STAB), 10 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2141,
Recall # Z-0414-2008;
31) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2142,
Recall # Z-0415-2008;
32) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2161,
Recall # Z-0416-2008;
33) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2164,
Recall # Z-0417-2008;
34) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643,
Recall # Z-0418-2008;
35) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650,
Recall # Z-0419-2008;
36) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652,
Recall # Z-0420-2008;
37) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712,
Recall # Z-0421-2008;
38) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713,
Recall # Z-0422-2008;
39) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF
96-2730, Recall # Z-0423-2008;
40) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF
96-2731, Recall # Z-0424-2008;
41) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF
96-2732, Recall # Z-0425-2008;
42) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF
96-2733, Recall # Z-0426-2008;
43) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF
96-2736, Recall # Z-0427-2008;
44) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310, Recall # Z-0428-2008;
45) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410, Recall # Z-0429-2008;
46) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206, Recall # Z-0430-2008;
47) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208, Recall # Z-0431-2008;
48) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406, Recall # Z-0432-2008;
49) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506, Recall # Z-0433-2008;

REASON: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
CLASS III
MANUFACTURER: Boston Scientific Corp., Miami, FL, by letter on June 14, 2007. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific Target, Transend EX Soft Tip Guide Wire .014 in /205cm, UPN: M001468060, Catalog Number: 46-806, Recall # Z-0122-2008
REASON: Mislabeling. Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by letter on October 12, 2007.Manufacturer: TFX Engineering Ltd., Teleflex Medical, Limerick, Ireland. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Recall # Z-0279-2008
REASON: Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 5, 2007:

CLASS II
MANUFACTURER: Cyberonics, Inc., Houston, TX, by correction notice in June of 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Cyberonics Neuro Cyberonics Prothesis System NCP Bipolar Lead, Model #300; Sterile, Single use only, Z-0171-2008;
b) Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only, Recall # Z-0172-2008;
c) Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only, Recall # Z-0173-2008
REASON: Dissolution/Fractures to the leads of the VNS Therapy System.

MANUFACTURER: Recalling Firm: Oridion Capnography Inc., Needham Heights, MA, by letters dated, August 21, 2007. Manufacturer: Oridion Medical 1987 Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
PRODUCT:
a) Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical, Recall # Z-0177-2008;
b) Capnostream20 Monitor with Masimor Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical, Recall # Z-0178-2008
REASON: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

MANUFACTURER: Edwards Lifesciences, Llc, Irvine, CA, by letter dated March 15, 2007. Firm initiated recall is complete.
PRODUCT: Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM stent, 80 CM Delivery System, Recall # Z-0179-2008
REASON: Failure to deploy.

MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, letter on/about November 1/2007. Manufacturer: Rai Wenzier Gmbh, Balgheim, Germany, Federal Republic of. Firm initiated recall is ongoing.
PRODUCT:
a) Pilling® Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Recall # Z-0266-2008;
b) Pilling® Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Recall # Z-0267-2008;
c) Pilling® Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws,Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Recall # Z-0268-2008
REASON: The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Knoxville, TN, by letter dated June 15, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner, Recall # Z-0269-2008;
b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Recall # Z-0270-2008;
c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Recall # Z-0271-2008;
d) Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Recall # Z-0272-2008;
e) Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Recall # Z-0273-2008
REASON: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.

MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated September 26, 2007. Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Recall # Z-0275-2008;
b) Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L;
Catalog No.: 01.00211.146, Recall # Z-0276-2008
REASON: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.

MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by letters on October 4, 2007. Firm initiated recall is ongoing.
PRODUCT: Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Recall # Z-0290-2008
REASON: Breakage. Breaking of the connecting foot that is on the distal surface of the instrument.

MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated October 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Recall # Z-0291-2008
REASON: The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.

MANUFACTURER: Recalling Firm: Toshiba America Medical Systems, Inc., Tustine, CA, by letters beginning on October 2, 2007. Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Otawara-Shi, Tochigi, Japan. Firm initiated recall is ongoing.
PRODUCT: Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008
REASON: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

MANUFACTURER: Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by letter on October 17, 2007. Manufacturer : Medtronic Navigation, Inc., Littleton, MA
PRODUCT: Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008
REASON: Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

MANUFACTURER: Xoran Technologies, Inc., Ann Arbor, MI, by visit between July 25, 2006 and August 10, 2007. Firm initiated recall is complete.
PRODUCT: Xoran MiniCAT for ENT. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging, Recall # Z-0296-2008
REASON: The hard drive may crash, resulting in loss of data from patient CT scans. 

 The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 28, 2007

CLASS I
MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letter on October 19, 2007 and by press statement on November 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001, Recall # Z-0212-2008
REASON: Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).

CLASS II
MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by WEB site posting on March 13, 2007 and by letter beginning on March 16, 2007.
Manufacturer: Boston Scientific Corporation CRM Ireland, Clomel, County Tipperary
Ireland. Firm initiated recall is ongoing.
PRODUCT:
a) Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872, Recall # Z-0047-2008;
b) Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator, ICD. Atrial and Ventricular Therapies, Recall # Z-0048-2008;
c) Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillators (ICD). (This model is not available in the USA), Recall # Z-0049-2008;
d) Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter
Defibrillators (ICD). Recall # Z-0050-2008;
e) Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Recall # Z-0051-2008;
f) Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. (* models are not available in the USA), Recall # Z-0052-2008;
g) Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M157, M159), Guidant CONTAK RENEWAL 4 AVT (Models M170, M175)*, Guidant CONTAK RENEWAL 4 AVT HE (Models M177 and M179)*. Cardiac Resynchronization Therapy Defibrillator (CRT-D). (* models are not available in the USA), Recall # Z-0053-2008;
REASON: Erroneous Display/Atypical Charge Time Behavior: 1)-End of Life (EOL) or Elective Replacement Indicator (ERI) is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2) Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time .

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on October 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F, Recall # Z-0174-2008
REASON: Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped with a Seat Lift, seat may not fully retract because of incorrect Seat-On Lift bracket Installation.

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on May 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Recall # Z-0175-2008
REASON: Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped with a Seat Lift, seat may not fully retract because of incorrect Seat-On Lift bracket Installation.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on November 9, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips, Voxel Q workstations, utilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Recall # Z-0180-2008
REASON: Incorrect simulation and/or beam placement: An anomaly has been identified with the Philips VoxelQ workstation utilizing AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 when computing absolute patient marking coordinates with data containing reconstruction offsets from the Mx800, the Mx8001DT, and the Brilliance 6, 10, 16, 16P, and Big Bore CT systems. When data from these systems contain reconstruction offsets, the absolute marking coordinates computed within Virtual Fluoroscopy package can be incorrect. Absolute patient marking coordinates computed on data without any reconstruction offsets are correct.

MANUFACTURER: Applied Biotech, Inc., San Diego, CA, by letter on September 28, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Clearview, hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Recall # Z-0244-2008;
b) Clearview hCG Combo Waived for urine & Moderate for serum, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Recall # Z-0245-2008
REASON: Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity; therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 18, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/Ref 141232, Recall # Z-0255-2008
REASON: Mislabeled as to size. The package actually contained a 71 mm tray.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letter on November 10, 2007. Manufacturer: Inpeco Spa, Segrate, Italy. Firm initiated recall is ongoing.
PRODUCT: Abbott Accelerator APS System Input/Output Module (IOM); List Number: 7L01-01, Recall # Z-0257-2008
REASON: Sample problems. Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlier, which may result in Sample ID mis-association, sample contamination and/or a sample being reprocessed to remain on the Priority Output Lane without any associated tests downloaded for reprocessing. The other two conditions are related to Sample Identification (SID) usage and lower case alpha characters and APS work cell configuration.

MANUFACTURER: Recalling Firm: Baxter Bioscience, Westlake Village, CA, by letter dated October 24, 2007. Manufacturer: Baxter Healthcare Corporation Medication Delivery Division, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Recall # Z-0263-2008
REASON: Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.

MANUFACTURER: Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter on October 10, 2007. Manufacturer: B. Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.
PRODUCT: Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP.. (The VenaTech LP vena cava filter is pre-loaded in a syringe (cartridge) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either via the femoral or jugular approach.), Recall # Z-0264-2008
REASON: Sterility (package integrity) compromised. Package sealing problem leaving packaging partially open on one of the four sealed Tyvek pouch edges.

MANUFACTURER: Recalling Firm: Abbott Laboratories Inc., South Pasadena, CA, by letter on August 10, 2007. Manufacturer: Thermo Fisher Microgenics, Fremont, CA. Firm initiated recall is ongoing.
PRODUCT: Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Recall # Z-0288-2008
REASON: Incorrect Calibrator values. Changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.

MANUFACTURER: Metrika, Inc., Sunnyvale, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.
PRODUCT: A1CNOW+ with sampler 10-Test Kits (Product No: 3022), (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care, Recall # Z-0289-2008
REASON: Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

CLASS III
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by telephone and fax on September 25, 2007. Firm initiated recall is ongoing.
PRODUCT: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD, Recall # Z-0256-2008
REASON: Mislabeling. Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive).

MANUFACTURER: Recalling Firm: Boston Scientific Target, Fremont, CA, by letter dated July11, 2007. Manufacturer: Boston Scientific Corp-Plymouth Tech. Center, Plymouth, MN. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number: 10042, Made in USA, Recall # Z-0259-2008;
b) Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: Recall # Z-0260-2008
REASON: Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 21, 2007

CLASS II
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters dated August 20 and August 23, 2007.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Philips Medical System - BV Pulsera Mobil C-arms with Remote Control Option, Recall # Z-0059-2008;
b) Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option, Recall # Z-0060-2008
REASON: System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letter on July 13, 2007 and July 23, 2007. Manufacturer: Depuy CMW, Blackpool, Lancashire, UK. Firm initiated recall is ongoing.
PRODUCT: SmartSeal Wedge Femoral Pressurizer; Product Code/Catalog No: 3206002. This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures, Recall # Z-0176-2008
REASON: Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
PRODUCT: GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems, Recall # Z-0181-2008
REASON: Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.MANUFACTURER: Pacific Bioscience Lab, Inc., Bellevue, WA, by press release and its Website on August 30, 2007, Firm initiated recall is ongoing.

PRODUCT: Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Recall # Z-0182-2008
REASON: Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Product Description : GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, Recall # Z-0183-2008
REASON: Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 27, 2007. Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is ongoing.
PRODUCT: Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Recall # Z-0214-2008
REASON: Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

MANUFACTURER: Recalling Firm: SKF USA Inc., Norristown, PA, by letter on or about July 24, 2007. Manufacturer: Magnetic Elektromotoren, Liestal, Switzerland. Firm initiated recall is ongoing.
PRODUCT:
a) Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, Recall # Z-0215-2008;
b) Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, Recall # Z-0216-2008;
c) Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000,Recall # Z-0217-2008
REASON: Sudden failure of the actuator during lifting operation.

MANUFACTURER: Stryker Medical Div. of Stryker Corporation, Portage MI, by letter dated September 24, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker Zoom (Atlas) powered patient transport stretcher, Model 660, Recall # Z-0219-2008;
b) Stryker Transport wheeled stretcher, Model 720, Recall # Z-0220-2008;
c) Stryker Transport wheeled stretcher, Model 721, Recall # Z-0221-2008;
d) Stryker OEM wheeled stretcher, Model 722, Recall # Z-0222-2008;
e) Stryker Transport wheeled stretcher, Model 735 (ST104), Recall # Z-0223-2008;
f) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1001,Recall # Z-0224-2008;
g) Stryker Trauma wheeled stretcher, Model 1002, Recall # Z-0225-2008;
h) Stryker M-Series wheeled stretcher, Model 1005 (SM104), Recall # Z-0226-2008;
i) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1009, Recall # Z-0227-2008;
j) Stryker M-Series wheeled stretcher, Model 1015 (SM204), Recall # Z-0228-2008;
k) Stryker Trauma wheeled stretcher, Model 1020, Recall # Z-0229-2008;
l) Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Recall # Z-0230-2008;
m) Stryker Eye Surgery (Head/Neck Surgery) wheeled stretcher, Model 1069, Recall # Z-0231-2008;
n) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1210, Recall # Z-0232-2008;
o) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1211, Recall # Z-0233-2008;
p) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Recall # Z-0234-2008;
q) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1501, Recall # Z-0235-2008;
r) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Recall # Z-0236-2008;
s) Stryker Renaissance Series PACU wheeled stretcher, Model 1710, Recall # Z-0237-2008;
t) Stryker Renaissance Series PACU wheeled stretcher, Model 1711, Recall # Z-0238-2008;
u) Stryker Renaissance Series PACU wheeled stretcher, Model 1731,Recall # Z-0239-2008
REASON: The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Recall # Z-0240-2008
REASON: False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the side rail being able to be lowered without pulling on the release handle.

CLASS III
MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on August 29, 2007. Manufacturer: Matsushita Electric Industrial Co., Ltd. - Med. Sys. Division, Yokohama City, Kanagawa, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B,V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008;
b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0, Recall # Z-0254-2008
REASON: Multiple problems including: (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 14, 2007:

CLASS I
MANUFACTURER: Welch Allyn Protocol, Inc, Beaverton, OR, by letter dated October 26, 2007, and by press release on October 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E; Recall # Z-0129-2008
REASON: Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.

CLASS II
MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter on July 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphates Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution., Recall # Z-0064-2008
REASON: Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.

MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by visit on August 2007. Manufacturer: Suinsa, Madrid, Spain. Firm initiated recall is ongoing.
PRODUCT: Sunisa Flexi-DT S0014115 Digital Table Flexi-DT, 115-240 V // Internal Battery 24V, 4-2A Internal Battery 8A, 50-60Hz. Model Numbers 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Recall # Z-0075-2008
REASON: Suinsa Flex-DT Table - Reports of several problems including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potential risk of falling to patient and/or operator.

MANUFACTURER: Encore Medical, Lp, Austin, TX, by telephone, e-mail and letters beginning on August 2, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Foundation® Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; Recall # Z-0082-2008;
b) Foundation® Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; Recall # Z-0083-2008;
c) Foundation® Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; Recall Z-0084-2008;
d) Foundation® Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; Recall # Z-0085-2008;
e) Foundation® Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; Recall # Z-0086-2008;
f) Foundation® Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; Recall # Z-0087-2008;
g) Foundation® Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; Recall # Z-0088-2008;
h) Foundation® Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; Recall # Z-0089-2008;
i) Foundation® Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048;Sterile; assembly required by physician prior to implant; Recall # Z-0090-2008;
j) Foundation® Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; Recall # Z-0091-2008;
k) Foundation® Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050;Sterile; assembly required by physician prior to implant; Recall # Z-0092-2008;
l) Foundation® Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; Recall # Z-0093-2008;
m) Foundation® Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; sterile; assembly required by physician prior to implant; Recall # Z-0094-2008;
n) Foundation® Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; Recall # Z-0095-2008;
o) Foundation® Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; Recall # Z-0096-2008;
p) Foundation® Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; Recall # Z-0097-2008;
q) Foundation® Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; Recall # Z-0098-2008;
r) Foundation® Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; Recall # Z-0099-2008
REASON: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

MANUFACTURER: Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, by letter on September 18, 2007. Manufacturer: Smiths Medical, Kent, UK. Firm initiated recall is ongoing.
PRODUCT: Portex perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090, Recall # Z-0100-2008
REASON: Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letters on July 15, 2007. Manufacturer: GE Medical Systems, Kretztechnik GmbH & Co. OHG, Zipf, Austria. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008
REASON: When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.

MANUFACTURER: Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic Sofamor Danek, Warsaw, IN, by letter dated September 4, 2007. Manufacturer: Zinnanti Surgical Design LLC, Hershey, PA. Firm initiated recall is ongoing.
PRODUCT: Medtronic Sofamor Danek METRx ™ System Bayonet Electrosurgical Pencil, sterile; REF (P/N) 9560575; Recall # Z-0114-2008
REASON: Packaging weakness may compromise sterility and instructions for use are inadequate.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on October 1, 2007. Firm initiated recall is ongoing.
PRODUCT: The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243; Recall # Z-0121-2008
REASON: The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.

MANUFACTURER: Recalling Firm: Karl Storz Endoscopy America, Inc., Culver City, CA, by letter on September 10, 2007. Manufacturer: Mpe, Inc., Milwaukee, WI. Firm initiated recall is ongoing.
PRODUCT: Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product number: 26601EQ-KT, Recall # Z-0144-2008
REASON: Outflow Difference. The accuracy of the equipment displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 26, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Mevatron KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 1940753; Recall # Z-0155-2008;
b) Mevatron KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 8515520 and 9822685; Recall # Z-0156-2008;
c) Mevatron KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401522; Recall # Z-0157-2008;
d) Mevatron KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 9411588 and 9822693; Recall # Z-0158-2008;
e) Mevatron-2 6300, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401316; Recall # Z-0159-2008;
f) Mevatron M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401407; Recall # Z-0160-2008;
g) Mevatron M-2 6740, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401506; Recall # Z-0161-2008;
h) Mevatron MD-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401654; Recall # Z-0162-2008;
i) Mevatron MDX-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401746; Recall # Z-0163-2008;
j) Oncor Avant Garde, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5863472; Recall # Z-0164-2008;
k) Oncor Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 7360204 and 7360717; Recall # Z-0165-2008;
l) Oncor Impression Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),Model Number: 5857912; Recall # Z-0166-2008;
m) Oncor Impression, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5857920; Recall # Z-0167-2008;
n) Mevatron M2/Primus Mid, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number 1940035,; Recall # Z-0168-2008;
o) Primus Plus, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 4504200; Recall # Z-0169-2008
REASON: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha WI, by field service visits in December 2006. Manufacturer: GE Hangwei Medical Systems Co., LTD, Beijing PR, China. Firm initiated recall is complete.
PRODUCT: Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8; Recall # Z-0170-2008
REASON: Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letter on June 25, 2007. Firm initiated recall is ongoing.
PRODUCT: Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems, Recall # Z-0213-2008
REASON: Unexpected loss of Treatment Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.

MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letters on August 30, 2007. Manufacturer: Cardinal Health 303, Inc., Creedmoor, NC. Firm initiated recall is ongoing.
PRODUCT: Texium Closed Male Luer (CML), Model Number: 10012241, Recall # Z-0218-2008
REASON: Leaks. There is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue).

MANUFACTURER: OPTI Medical Systems, Inc., Roswell, GA, by e-mail and fax on/about July 18, 2007. Firm initiated recall is ongoing.
PRODUCT: OPTI® LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, Recall # Z-0119-2008
REASON: Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.

CLASS III

MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letter on August 27, 2007. Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.
PRODUCT: Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall Number : Z-0081-2008
REASON: An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting no episodes have occurred, instead of indicating that no data is available.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 7, 2007:

CLASS II
MANUFACTURER: Recalling Firm: Bio-Logic Systems Corp., Mundelein, IL, by letters dated July 26, 2007. Manufacturer: TLK Industries Inc., Palatine, IL. Firm initiated recall is ongoing.
PRODUCT: Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video, Recall Z-0001-2008
REASON: Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.

MANUFACTURER: Medtronic, Inc., Danvers, MA, by letter dated August 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic Export XT Aspiration Catheter, 6F Model Numbers: G146200USB (US Distribution) G1452006B (Outside US), Recall # Z-0063-2008
REASON: Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on or about July 24, 2007 and letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT:
a) Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)-- Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Recall # Z-0076-2008;
b) Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116, Recall # Z-0077-2008
REASON: Incorrect Product -- Mislabeled as to size. An 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

MANUFACTURER: Gambro BCT, Inc., Lakewood, CO, by telephone beginning September 17, 2007 and letters on September 22, 2007. Firm initiated recall is ongoing.
PRODUCT: Spectra Optia apheresis system, a blood component separator. Part No. 61000, Recall # Z-0078-2008
REASON: Under specific conditions, apheresis machine could return up to 60 mL. of air to the patient.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on May 9, 2007 and November 1, 2007. Firm initiated recall is complete.
PRODUCT: ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612, Recall # Z-0080-2008
REASON: The plasma spray may delaminate from the proximal portion of the humeral stem.

MANUFACTURER: Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 25, 2007. Manufacturer: Philips Medical Systems Technolo, Haifa, Israel. Firm initiated recall is ongoing.
PRODUCT: a) Brilliance CT Systems, 40 slice configuration. Computed tomography scanner, Model No. 728231, Recall # Z-0110-2008;b) Brilliance CT Systems 64 slice configuration. Computed tomography scanner. Model No. 728235, Recall # Z-0111-2008
REASON: Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter on August 28, 2007. Manufacturer: Boston Scientific Corporation, Global Park, Heredia,Costa Rica. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 UPN Number: M00513321 REF: 1332-20, Recall # Z-0116-2008;
b) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20, Recall # Z-0117-2008;
c) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40, Recall # Z-0118-2008;
REASON: Device lacked manufacturing finishing process resulting in scope damage.

CLASS III
PRODUCT: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, Recall # Z-0065-2008
MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letters on September 5, 2007 and September 19, 2007. Firm initiated recall is complete.
REASON: Incorrect Instructions. The packages insert states to add 100L of conjugate; it should state to add 100uL.

MANUFACTURER: Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated September 20, 2007. Manufacturer: Aomori Olympus Co Ltd, Aomori, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Recall # Z-0105-2008;
b) Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Recall # Z-0106-2008;
c) Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Recall # Z-0107-2008;
d) Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Recall # Z-0108-2008
REASON: Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter dated September 10, 2007. Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303, Recall # Z-0109-2008
REASON: Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.

MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by letter dated July 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; Item # 660/75 1 liter and Item 660/85 /4 liter poly bottles, Recall # Z-0133-2008
REASON: Batch Out of Specifications. The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 31, 2007

CLASS I
MANUFACTURER: Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0070-2008
REASON: Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.

CLASS II
MANUFACTURER: Recalling Firm: Smith and Nephew, Inc., Memphis, TN, by telephone on July 12, 20007 and letter dated July 24, 2007. Manufacturer: Finsbury Orthopaedics, Leatherhead, UK. Firm initiated recall is ongoing.
PRODUCT:
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component, Recall # Z-0017-2008
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component, Recall # Z-0018-2008
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component, Recall # Z-0019-2008;
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component, Recall # Z-0020-2008;
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component, Recall # Z-0021-2008;
f) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component, Recall # Z-0022-2008;
g) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component, Recall # Z-0023-2008;
h) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component, Recall # Z-0024-2008;
i) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component, Recall # Z-0025-2008;
j) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component, Recall # Z-0026-2008;
k) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component, Recall # Z-0027-2008;
l) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component, Recall # Z-0028-2008;
m) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component, Recall # Z-0029-2008;
n) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component, Recall # Z-0030-2008;
o) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component, Recall # Z-0031-2008;
p) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component, Recall # Z-0032-2008;
q) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component, Recall # Z-0033-2008
REASON: The carton label may not reflect the correct size of the Acetabular cup.

MANUFACTURER: Remington Medical, Inc., Alpharetta, GA, by letter dated July 23, 2007. Firm initiated recall is ongoing.
PRODUCT: Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Recall # Z-0058-2008
REASON: Sterility, inadequate -- Pathway may not be sterile as labeled.

MANUFACTURER: Philips, Medical Systems, Andover, MA, by letter dated September 4, 2007. Firm initiated recall is ongoing.
PRODUCT: HeartStart XL Defibrillator/Monitor, Model: M4735A, Recall # Z-0062-2008
REASON: Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.

MANUFACTURER: Becton Dickinson and Company, Waltham, MA, by letter dated August 9, 2007. Firm initiated recall is complete.
PRODUCT: BD Microkeratome K3000 and K4000; Catalog Number: 378660, Recall # Z-0066-2008
REASON: Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on August 30, 2007. Firm initiated recall is ongoing.
PRODUCT: a) Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Sterile, Made in USA, Recall # Z-0072-2008; b) HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole
Plug; Hip prosthesis component. Sterile; made in USA, Recall # Z-0073-2008
REASON: Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

MANUFACTURER: Steris Corporation Hopkins Facility, Mentor, OH, by telephone on September 12, 2007, and by letters on September 28, 2007. Firm initiated recall is ongoing.
PRODUCT: Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope., Recall # Z-0101-2008
REASON: Loose or missing adaptor. The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor’s housing. The absence of adaptor #6’s center insert may affect the sterilization process of the attached endoscope.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on August 9, 2007 and by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics Apical Hole Plug, 3/8 – 24 threaded, TI-6AL-4V alloy, sterile; REF123741, Recall # Z-0102-2008
REASON: Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by telephone, interoffice memo and letter on September 11, 2007. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO, Recall # Z-0103-2008;
b) Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico, Recall # Z-0104-2008
REASON: Missing holes: Catheters are missing the catheter's side holes.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
MANUFACTURER: Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0070-2008
REASON: Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 24, 2007

CLASS II
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on February 22, 2007, Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
PRODUCT: FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008
REASON: Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter, on or about September 28, 2007. Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems. Catalog Number 366356, Recall # Z-0044-2008;
b) Microtainer Safety Flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade Length; 1.0mm blade width; Becton Dickinson Vacutainer System.Catalog number 365759, Recall # Z-0045-2008;
c) Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems, Catalog number 366357, Recall # Z-0046-2008
REASON: Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.

CLASS III
MANUFACTURER: Esa Biosciences, Inc., Chelmsford, MA, by telephone and letter on September 20, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762, Recall # Z-0042-2008;
b) ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142, Recall # Z-0043-2008
REASON: Level 1 and Level 2 Control values were incorrectly assigned.

MANUFACTURER: Z