Reported Feb 5, 2014 · Terminated
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany…
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 Dr · Mahwah, NJ · 07430-2002
Is this the product you have?
- Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen
- Germany distributed in the USA byStryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip
- Guide Wires for Smooth Tip Guide Wires
T2 Tibial Nailing SystemsT2 Femoral Nailing SystemsT2 Ankle Nailing Systemsand T2 Humerus Nailing Systems
- Lot codes and dates
Catalog Number 1806-0073S Lot Code K06C3B4K05ECF3K05ECF2K057298K0432D3
- Amount recalled
- 34 units
Where it was sold
Why it was recalled
Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile.
This product could cause temporary or reversible health problems — stop using it.
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