FDA Recall
Terminated
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
Recall: Z-0214-2008
·
Initiated September 27, 2007
Recall
- Recall Number
- Z-0214-2008
- Event Number
- 45106
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- September 27, 2007
- Posted
- November 16, 2007
- Terminated
- May 8, 2008
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002
Description
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
Reason
Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.
Action
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.
Distribution
Nationwide
Quantity
50