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
Recall
- Recall Number
- Z-0849-2014
- Event Number
- 67055
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- November 7, 2013
- Posted
- January 28, 2014
- Terminated
- March 31, 2015
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002
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
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.
The firm, Stryker, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 17, 2013 to its customers via e-mail. Preliminary notification letters and Product Accountability Forms were sent via FedEx on November 15, 2013 with return receipt to the Stryker locations. Notification and Product Accountability Forms were sent 12/18/2013 via Fed Ex with return receipt. Updated letters were sent via Fed Ex on 12/19/2013 with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine affected devices in local inventory as well as retrieve any devices located in hospitals; inform users of the Medical Device Removal and pass this to all those individuals who need to be aware within your organization; return all affected products available to your location to: Stryker Osteosynthesis, c/o Colleen O'Meara, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ, 07430, REF: PFA#2013-168 or contact Stryker customer service and refer to PFA #2013-166 for returning the product to us; complete and return the enclosed Business Reply Form and fax a copy to: 1-865-251-3635 or email a copy to Recall Coordinator at [email protected], and keep a copy of the completed and executed Business Reply form for your records. If you have any further questions, contact Manager, Regulatory Compliance at 1-201-972-2100 or email: [email protected].
US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
34 units