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.
FDA Recall Z-1601-2009 · Posted 2009-07-07
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-05-05
Date Terminated2009-07-07
Product Quantity8
Reason for Recall
A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution (AL, OH, MN, NM, and CA).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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