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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Spine
Lot Codes / Batch Numbers
Lot Codes: 056398 and 056399.
Products Sold
Lot Codes: 056398 and 056399.
Stryker Spine is recalling Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker due to DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
Recommended Action
Per FDA guidance
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".
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026