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Zimmer Natural-Knee II System Modular Cemented Tibial… recallZ-0871-2009 · Zimmer Inc. · initiated Nov 25, 2008

Terminated All recalls posted in January 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

Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.

FDA root cause category: Packaging process control

What the company is doing

Zimmer distributors were notified by email of letter dated 11/25/08 on 11/25/08. This letter is entitled "URGENT: DEVICE RECALL." Secondary consignees/user accounts were notified by a copy of the 11/25/08 letter, which was sent on or before 12/05/08. Consignees were instructed to stop using the product and to return it to Zimmer. For further information, please contact Zimmer, Inc. by telephone by dialing 800-613-6131.

Recall details

Recall number
Z-0871-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 25, 2008
Posted by the FDA
Jan 9, 2009
Recalling firm
Zimmer Inc.
Quantity
10
Product code
JWH
FDA submissions
K023528
Distribution
Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.

Product description

Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. These are single use implantable devices sold sterile.

Code information (models, lots, serial numbers)

Lot 60830979.

Other devices under the same FDA submission

1 device cleared under K023528 — 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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