Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker Spine SAS, Cestas, F
FDA device recall Z-0936-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
- 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".
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MDM
- Quantity affected
- 37
- Distribution
- Nationwide Distribution --- including state of NJ.
- Date initiated
- 2006-09-08
- Date posted
- 2009-02-03
- Date terminated
- 2009-02-05
- Location
- Allendale, NJ
Monitor recalls programmatically
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