—#81876

Product

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.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P060037
Affected lot / code info: Lots 61204820, 61215983, 61219677,61219684 and 61227758.

Why it was recalled

The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-04-17
Posted by FDA: 2009-06-25
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.