Reported Jan 2, 2013 · Terminated
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Drive · Mahwah, NJ · 07430
Is this the product you have?
- 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 byHowmedica Osteonics Corp., 235 Corporate Drive
- Lot codes and dates
- Catalog No1806-0073S
- Lot Code123596
- Amount recalled
- 100 units (73 units US; 27 units OUS)
Where it was sold
Why it was recalled
During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
This product could cause temporary or reversible health problems — stop using it.
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