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Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior… recallZ-1521-2009 · Zimmer Inc. · initiated Apr 17, 2009

Terminated All recalls posted in June 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-1521-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 17, 2009
Posted by the FDA
Jun 25, 2009
Recalling firm
Zimmer Inc.
Quantity
1
Product code
NJL
FDA submissions
P060037
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.

Product description

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.

Code information (models, lots, serial numbers)

Lot 61219714.

Other devices under the same FDA submission

26 devices cleared under P060037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 52003).

Sources and updates

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