—#90334

Product

Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K974054
Affected lot / code info: Catalog No.: 1059-4513 Lot Code: WDXMLE

Why it was recalled

One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.

Root cause (FDA determination)

Process control

Action the firm took

Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2010-03-31
Posted by FDA: 2010-05-12
Terminated: 2010-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.