FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S; Sterile, TI Alloy; Stryker Trauma GmbH, Germany; Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
- Recall number
- Z-0844-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S; Sterile, TI Alloy; Stryker Trauma GmbH, Germany; Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
- Status
- Terminated
- Initiated
- 2009-12-29
- Posted
- 2010-02-24
- Terminated
- 2012-08-06
- Reason
- Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Root cause
- Packaging
- Action
- Urgent Product Recall notification letters were sent to branches on 12/29, 2009, with a corrected version that included a list of catalog numbers and code numbers on January 11, 2009. Letters were also sent by Fed Ex on January 11, 2009 to Hospital Risk Management, Chief of Orthopaedics and surgeons who may have used the device. The letters identified the affected product, described the issue, and the hazards involved. The letter also asked customers to examine their inventory and hospital locations to identify the affected product. They are to retrieve all affected product and return it to their branch or agency warehouse for reconciliation. Customers are to reconcile all products utilizing the Product Recall Accountability Form. Questions should be directed to 201-972-2100.
- Quantity
- 702 total, all sizes
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- lot codes: K101051, K157119, K185536, K210257, K549634, K735538, K769105, K779949, K837690, K868843, and K893064.
- 510(k) numbers
- ["K051590"]
- PMA numbers
- not on file
- Product code
- HSB
- 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