FDA Medical Device Recalls (openFDA)
Stryker Spine: Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417 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.
- Recall number
- Z-1967-2010
- Recalling firm
- Stryker Spine
- Product
- Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417 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.
- Status
- Terminated
- Initiated
- 2010-05-13
- Posted
- 2010-07-08
- Terminated
- 2012-09-06
- Reason
- 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
- 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
- 141 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot numbers: 066357 - 067540 - 06D477 - 071454 - 072680 - 074606 - 075349 - 076578 - 07C643 - 07H726 - 082973 - 084259.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28