Recall Z-0936-2009 ยท MDM Instrument, Manual, Surgical, General Use
Stryker Spine
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.
| Date | Feb 3, 2009 (initiated Sep 8, 2006) |
| Status | Terminated |
| Reason | DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock. |
| Root cause | Device Design |
| Action | 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". |
| Quantity | 37 |
| Distribution | Nationwide Distribution --- including state of NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.