Z-0610-2013Class II

Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing...

Name: Z-0610-2013 Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-08-06
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-08-06 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in... on 2012-08-06. FDA classified it as Class II and gives the reason as "During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0610-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Posted: 2012-12-22
Terminated: 2013-09-11
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter & Acknowledgement form dated August 7, 2012 via FedEx Return Receipt to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to inform their users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within their organization; return all affected products available at their location to: Stryker Osteosynthesis, 325 Corporate Drive, Mahwah, NJ 07430 REF: PFA#2012-124 or contact Stryker customer service; complete and sign the enclosed Product Recall Acknowledgement Form and Fax to 1-855-251-3635 or email to Recall Coordinator at [email protected] and keep a copy of their records. If you have any questions, contact the Manager, Regulatory Compliance, at 1-201-972-2100 or email: [email protected].
Quantity in commerce: 100 units (73 units US; 27 units OUS)
Distribution: Worldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom.
Product codes and lots: Catalog No: 1806-0073S Lot Code:123596

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0610-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0610-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-21

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