Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, st
FDA device recall Z-1521-2009 · posted 2009-06-25 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
- Action taken
- Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NJL
- Quantity affected
- 1
- Distribution
- Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsy
- Date initiated
- 2009-04-17
- Date posted
- 2009-06-25
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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