—#90282

Product

Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.

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: Lot code - L3988

Why it was recalled

Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.

Root cause (FDA determination)

Error in labeling

Action the firm took

Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- FL, MN, & OR.

Timeline

Recall initiated: 2010-03-29
Posted by FDA: 2010-05-13
Terminated: 2012-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90282. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.