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Zimmer Gender Solutions Nexgen Complete Knee Solution… recallZ-0501-2010 · Zimmer Inc. · initiated Nov 13, 2009

Terminated All recalls posted in December 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 inner package may interfere with the outer seal, resulting in lack of assurance of sterility.

FDA root cause category: Packaging process control

What the company is doing

Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.

Recall details

Recall number
Z-0501-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 13, 2009
Posted by the FDA
Dec 14, 2009
Recalling firm
Zimmer Inc.
Quantity
22
Product code
JWH
FDA submissions
K060370
Distribution
Nationwide, Korea and Switzerland.

Product description

Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.

Code information (models, lots, serial numbers)

Lot 61042477.

Other devices under the same FDA submission

17 devices cleared under K060370 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page