Z-0481-2011

T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by...

Name: Z-0481-2011 T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-08-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-08-02 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah... on 2006-08-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0481-2011
Status: Terminated
Initiated: 2006-08-02
Posted: 2010-11-26
Terminated: 2013-11-22
Recalling firm: 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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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.
FDA 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 in commerce: 8 sets
Distribution: Nationwide Distribution: To one location in New Jersey.
Product codes and lots: Catalog Number 1806-3213 and 18063211; Lot codes: K726345 and K679684

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)