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Terminated

Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF 00-5964-014-51.

FDA Recall Z-1521-2009 · Posted 2009-06-25

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeNJL
Date Initiated2009-04-17
Date Terminated2009-11-12
Product Quantity1

Reason for Recall

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

Firm 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.

Root Cause

Employee error

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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