Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Trauma GmbH, 24232 Schenjrchen, Germany; distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended for temporary fixation, correction, or stabilization of the right femur.
Recall
- Recall Number
- Z-2340-2010
- Event Number
- 56364
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 23, 2010
- Posted
- September 2, 2010
- Terminated
- August 6, 2012
- Address
- 325 Corporate Drive, Mahwah, NJ, 07430
Description
Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Trauma GmbH, 24232 Schenjrchen, Germany; distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended for temporary fixation, correction, or stabilization of the right femur.
The nail has no thread for the set screw hindering insertion.
Urgent Product Recall letters were sent on July 23, 2010 by Federal Express to Stryker branches. A corrected letter was sent on July 26, 2010 to correct an error in the size of the screw. Additionally, letters were sent on July 26, 2010 to Hospital Risk Managers, Chief of Orthopaedics and Surgeons. The letter identified the affected product, explained the issue, discussed the potential hazard, and the risk mitigation. Customers are to examine their inventory, retrieve all affected product and return it; then reconcile all products on the Product Recall Acknowledgement Form and fax it back. Questions should be directed towards Richard Wolyn at 201-972-2100.
Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.
12 units