FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ
- Recall number
- Z-0481-2011
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ
- Status
- Terminated
- Initiated
- 2006-08-02
- Posted
- 2010-11-26
- Terminated
- 2013-11-22
- Reason
- The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.
- Root cause
- Other
- Action
- Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product. Stryker can be contacted about this issue at 201 831-5118.
- Quantity
- 8 sets
- Distribution
- Nationwide Distribution: To one location in New Jersey.
- Lot, serial or model codes
- Catalog Number 1806-3213 and 18063211; Lot codes: K726345 and K679684
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- 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