—#64970

Product

Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24232 Schonkirchen, Germany Distributed in the United States by Howmedica Osteonics Corp.; 325 Corporate Drive, Mahwah, NJ 07430

510(k) numbers: K003018
Affected lot / code info: Catalog number: 189605970S: Lot Code K871252

Why it was recalled

Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

Root cause (FDA determination)

Packaging process control

Action the firm took

Urgent Product Recall letters were sent on September 27, 2007, to all Stryker Branches/Agencies and hospitals who received the product requesting them to remove and quarantine the product for Stryker pick-up.

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2007-09-27
Posted by FDA: 2007-11-16
Terminated: 2008-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64970. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.