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Zimmer Gender Solutions Natural Knee Flex System, Gender… recallZ-1477-2009 · Zimmer Inc. · initiated Apr 29, 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 tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.

FDA root cause category: Employee error

What the company is doing

Zimmer, Inc. issued an "Urgent: Device Recall" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.

Recall details

Recall number
Z-1477-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 29, 2009
Posted by the FDA
Jun 26, 2009
Recalling firm
Zimmer Inc.
Quantity
14
Product code
JWH
FDA submissions
K070214
Distribution
Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.

Product description

Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01. Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.

Code information (models, lots, serial numbers)

Lot Number: 60998487.

Other devices under the same FDA submission

14 devices cleared under K070214 — 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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