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March 29th: Ossur Announces Voluntary Recall of Certain Models of the Total Knee®

Iceland -- Ossur today announced a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee® prosthetic device. The company's initiation of the recall, effective immediately, is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee.

At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company.

The serial numbers of the affected knees, which were ordered from June 7th, 2005 to present, have been identified. The O & P facilities who have provided a Total Knee that contains the affected serial number will receive a letter and a phone call with the proper replacement procedure in the next few days.

In addition, Ossur has temporarily suspended sales and shipments of Total Knees until further notice. To expedite this process in the consideration of both its customers and patients, the implementation of a replacement program will be effective immediately.

Ossur has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision to implement this recall.

Ossur will continue to provide regular and frequent updates as more information becomes available. You may also access the company website at www.ossur.com for this information, in real time.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html

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

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