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Terminated

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.

FDA Recall Z-0936-2009 · Posted 2009-02-03

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeMDM
Date Initiated2006-09-08
Date Terminated2009-02-05
Product Quantity37

Reason for Recall

DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.

Firm 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".

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution --- including state of NJ.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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