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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker AVS AL Spacer Trial Inserter

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  Class 2 Device Recall Stryker AVS AL Spacer Trial Inserter see related information
Date Initiated by Firm September 08, 2006
Date Posted February 03, 2009
Recall Status1 Terminated 3 on February 05, 2009
Recall Number Z-0936-2009
Recall Event ID 50774
Product Classification Manual Surgical Instrument for General Use - Product Code MDM
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.
Code Information Lot Codes: 056398 and 056399.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Michele Klein
201-760-8256
Manufacturer Reason
for Recall		 DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
FDA Determined
Cause 2		 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 in Commerce 37
Distribution Nationwide Distribution --- including state of NJ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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