Z-0845-2010

Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; Sterile, TI Alloy; Stryker...

Name: Z-0845-2010 Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; Sterile, TI Alloy; Stryker...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-12-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-12-29 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; Sterile, TI Alloy; Stryker Trauma GmbH, Germany; Distributed in the US by... on 2009-12-29. The reason FDA records is "Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0845-2010
Status: Terminated
Initiated: 2009-12-29
Posted: 2010-02-24
Terminated: 2012-08-06
Recalling firm: Howmedica Osteonics Corp
Product: Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; 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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
Root cause tag: packaging
FDA 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 in commerce: 702 total, all sizes
Distribution: Nationwide Distribution.
Product codes and lots: lot codes: K125357, K158792, K185537, K199852, K227392, K452805, K455652, K461353, K624000, K732800, K769107, K782950, K785627, K820525, K858019, K863219, K868858, K893086, K951620, K963944, and K983458.

Product code HSB

K051590Class IIT2 Ankle Arthrodesis NailHowmedica Osteonics Corp. / cleared 2005-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)