Stryker Howmedica Osteonics Corp.
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
| Date | Nov 16, 2007 (initiated Sep 27, 2007) |
| Status | Terminated |
| Reason | Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 50 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003018 | TITAN TIBIAL NAIL Howmedica Osteonics Corp., Dec 15, 2000 |