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,

During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.

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].