Device 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,
Z-0610-2013
Product summary
- Event
- Event 63457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units (73 units US; 27 units OUS)
- Official record key
device-enforcement:Z-0610-2013
Official wording
Reason: During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
Code information: Catalog No: 1806-0073S Lot Code:123596
Distribution pattern: 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.
Derived failure modes
-
Manufacturing or process control
manufacturing of the affected lot a manufacturing error