Z-0936-2009

Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker Spine...

Name: Z-0936-2009 Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker Spine...
Creator: Stryker Spine
Published: 2006-09-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-09-08 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Osteonics... on 2006-09-08. The reason FDA records is "DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0936-2009
Status: Terminated
Initiated: 2006-09-08
Posted: 2009-02-03
Terminated: 2009-02-05
Recalling firm: Howmedica Osteonics Corp
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.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
Root cause tag: design
FDA 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 in commerce: 37
Distribution: Nationwide Distribution --- including state of NJ.
Product codes and lots: Lot Codes: 056398 and 056399.

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)