Device product
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker 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 Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
Z-0849-2014
Product summary
- Event
- Event 67055
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 units
- Official record key
device-enforcement:Z-0849-2014
Official wording
Reason: 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.
Code information: Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
Distribution pattern: US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
Derived failure modes
-
Sterility assurance
sterile barrier) may be compromised