Z-1961-2010

Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker Spine SAS, Cestas...

Name: Z-1961-2010 Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker Spine SAS, Cestas...
Creator: Stryker Spine
Published: 2010-05-13
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-05-13 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2... on 2010-05-13. The reason FDA records is "Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1961-2010
Status: Terminated
Initiated: 2010-05-13
Posted: 2010-07-08
Terminated: 2012-09-06
Recalling firm: Howmedica Osteonics Corp
Product: Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.
Quantity in commerce: 194 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: 063935 - 066351 - 067531 - 06D471 - 071447 - 072675 - 072735 - 074600 - 075343 - 076572 - 07C637 - 07H719 - 07H720 - 082967 - 084253.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)