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April 12th: Blackstone Medical, Inc. Issues Voluntary Recall of ICON™ Modular Fixation System

On December 27, 2005 Blackstone Medical, Inc. informed the FDA of a voluntary recall of its ICON™ Modular Fixation System. A notice was sent the same day to distributors and surgeons implanting the ICON™ Modular Fixation System. The product has been marketed since June, 2005. Components in the system may fail after the devices have been implanted.

This voluntary recall, subsequently classified as a Class I recall by the FDA on April 7th, 2006, includes components of system 54-9011. Blackstone Medical, Inc. initiated the recall after receiving reports of construct loosening in the early postoperative period. Blackstone Medical, Inc. verified the removal from distribution of remaining affected products that were not yet implanted.

The potential for injury due to failure of the implant will depend on the specific condition being treated, and the degree of postoperative healing. There may be potential for serious injury in specific patients.

There have been 484 surgical procedures in which the recalled devices have been implanted. To date, approximately 4% of the constructs have been reported as loose, and this has resulted in the surgical removal or revision of a number of the constructs. No deaths and no serious injuries other than surgery for device removal have been reported.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/oc/po/firmrecalls/blackstone04_12.html

If you have comments regarding this update, please email us at info@mdiconsultants.com
 

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