Recall Z-1522-2009 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Zimmer Inc.
Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size G Left , sterile, Zimmer, Warsaw, IN; REF 00-5964-017-51.
| Date | Jun 25, 2009 (initiated Apr 17, 2009) |
| Status | Terminated |
| Reason | The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 21 |
| 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 Pennsylvania and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.