FDAFDA · Food and drugs·Recall number Z-0849-2014
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
Published February 5, 2014 · Recall initiated: November 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
- Lot
- Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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