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.
Recall
- Recall Number
- Z-1601-2009
- Event Number
- 50093
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- May 5, 2006
- Posted
- July 7, 2009
- Terminated
- July 7, 2009
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430
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.
A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.
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.
Nationwide Distribution (AL, OH, MN, NM, and CA).
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