FDA Device

Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. 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.

Hazard

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.

What You Should Do

Remedy

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.

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Products

Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended f
Brand
Stryker Spine
UPC
Lot numbers: 063931 - 066347 - 067528 - 06D467 - 071443 - 072671 - 074595 - 075338 - 076568 - 07C633 - 07D769 - 07H715 - 082963 - 084249.

Units Affected

183

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