—#74712

Product

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 product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K915512
Affected lot / code info: Lot Code: 17800601.

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution (AL, OH, MN, NM, and CA).

Timeline

Recall initiated: 2006-05-05
Posted by FDA: 2009-07-07
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.