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NexGen Complete Knee Solution Stemmed Tibial recallZ-0120-2011 · Zimmer Inc. · initiated Jan 26, 2010

Terminated All recalls posted in October 2010

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

Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.

FDA root cause category: Employee error

What the company is doing

The firm sent an URGENT MARKET WITHDRAWAL to its sales force and distributors on 1/26/2010. The letter identifies the affected product and explains the reason for the Market Withdrawal. The letter also explains the clinical implications and instructs consignees to locate any unused devices and quarantine them immediately. A physical count should be carried out of all affected devices and recorded on the Inventory Return Certification Form that's included with the letter. A copy of the letter should be faxed to Zimmer, Inc. and the affected product should be returned along with the form to the firm.

Recall details

Recall number
Z-0120-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 26, 2010
Posted by the FDA
Oct 21, 2010
Recalling firm
Zimmer Inc.
Quantity
61 units
Product code
JWH
FDA submissions
K933785
Distribution
Worldwide Distribution -- US, Canada, Singapore Australia, and India.

Product description

NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 3, REF 00-5980-037-01, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.

Code information (models, lots, serial numbers)

Lot Number: 61313261.

Other devices under the same FDA submission

89 devices cleared under K933785 — 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 56701).

Sources and updates

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