Recall Z-0936-2009
Stryker Spine · initiated September 8, 2006
Product
Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Osteonics Corp., Mahwah, NJ.
Codes / lots: Lot Codes: 056398 and 056399.
Reason for recall
DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
FDA-determined cause: Device Design
Action taken
Market Withdrawal letters were sent out on September 8, 2006 to all branches who received device. The letter asked customers to examine their inventory and hospital consignment locations to identify the product. Also, customers needed to reconcile all products on the attached Product Accountability Form and fax a copy back. The affected products were to be retrieved and returned using the "Product Returns Procedure".
Details
- Recall number
- Z-0936-2009
- Initiated
- September 8, 2006
- Posted by FDA
- February 3, 2009
- Terminated
- February 5, 2009
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 37
- Distribution
- Nationwide Distribution --- including state of NJ.
- Recalling firm
- Stryker Spine, Allendale, NJ