Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker...
Stryker Howmedica Osteonics Corp. began a recall of Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24232 Schonkirchen, Germany Distributed... on . The reason FDA records is "Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0214-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Howmedica Osteonics Corp
- 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
- Reason for recall
- Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.
- Root cause tag
- packaging
- FDA 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 in commerce
- 50
- Distribution
- Nationwide
- Product codes and lots
- Catalog number: 189605970S: Lot Code K871252
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