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Zimmer NexGen Complete Knee Solution Legacy Knee Tibial… recallZ-0209-2007 · Zimmer Inc. · initiated Oct 12, 2006

Terminated All recalls posted in November 2006

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 polyethylene tibial articular surface may not lock into some of the tibial plates.

FDA root cause category: Other

What the company is doing

Consignees were notified by a letter dated 10/12/06 and sent to operating room supervisors and Zimmer distributors to cease using the product and to return it to the firm.

Recall details

Recall number
Z-0209-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 12, 2006
Posted by the FDA
Nov 22, 2006
Recalling firm
Zimmer Inc.
Quantity
18
Product code
JWH
FDA submissions
K963148
Distribution
Nationwide.

Product description

Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02.

Code information (models, lots, serial numbers)

Lot 60472442; exp. May 2011.

Other devices under the same FDA submission

6 devices cleared under K963148 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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