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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Howmedica Osteonics Corp.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
Distribution:
Distributed in: US, GA, IL, KY, MI, MO, NJ, TN, UT, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0849-2014
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Stryker Howmedica Osteonics
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.