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Duracon Total Knee, A-P Lipped Tibial Insert recallZ-1601-2009 · Stryker Howmedica Osteonics Corp. · initiated May 5, 2006

Terminated All recalls posted in July 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 Stryker Howmedica Osteonics Corp. 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

A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.

FDA root cause category: Labeling mix-ups

What the company is doing

A notification letter and product accountability form were sent via Federal Express on May 5, 2006 with return receipt to branch accounts that had received the affected product. For questions about the recall contact Stryker Howmedica Osteonics Corp. by calling 1-201-831-5000.

Recall details

Recall number
Z-1601-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 5, 2006
Posted by the FDA
Jul 7, 2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
8
Product code
JWH
FDA submissions
K915512
Distribution
Nationwide Distribution (AL, OH, MN, NM, and CA).

Product description

Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stryker, Ireland. Product No. 6642-1-611. The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only.

Code information (models, lots, serial numbers)

Lot Code: 17800601.

Other devices under the same FDA submission

11 devices cleared under K915512 — 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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