Recall Z-2340-2010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
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.
| Date | Sep 2, 2010 (initiated Jul 23, 2010) |
| Status | Terminated |
| Reason | The nail has no thread for the set screw hindering insertion. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K034002 | GAMMA3 NAIL SYSTEM Howmedica Osteonics Corp., Jan 15, 2004 |