Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24
FDA device recall Z-0214-2008 · posted 2007-11-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Quantity affected
- 50
- Distribution
- Nationwide
- Date initiated
- 2007-09-27
- Date posted
- 2007-11-16
- Date terminated
- 2008-05-08
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITAN TIBIAL NAIL (K003018) | Howmedica Osteonics Corp. | 2000-12-15 |