FDA Medical Device Recalls (openFDA)
Stryker Spine: Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
- Recall number
- Z-2033-2012
- Recalling firm
- Stryker Spine
- Product
- Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
- Status
- Terminated
- Initiated
- 2012-01-13
- Posted
- 2012-07-19
- Terminated
- 2013-07-29
- Reason
- Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.
- Root cause
- Device Design
- Action
- Stryker sent an "URGENT PRODUCT RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was included for customers to complete and return via fax to Regulatory Compliance at 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this recall.
- Quantity
- 273 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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