—#70289

Product

Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ 07430 Authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan Cedex, France

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.

Why it was recalled

The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.

Root cause (FDA determination)

Process control

Action the firm took

An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.

Timeline

Recall initiated: 2005-04-15
Posted by FDA: 2008-08-27
Terminated: 2008-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.