Recall Z-1626-2008 ยท HXX Screwdriver
Stryker Howmedica Osteonics Corp.
Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place th
| Date | Sep 16, 2008 (initiated Feb 22, 2008) |
| Status | Terminated |
| Reason | Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw. |
| Root cause | Finished device change control |
| Action | On February 22, 2008 Urgent Product Recall notification letters were sent to Stryker Branches/Agencies, Risk Management Departments at hospitals and surgeons via Federal Express. If you have any questions contact Rita Intorrella at (201) 831-5825 or the Hip Fracture Team at (201) 831-5291. |
| Quantity | 43 total (single and kits) |
| Distribution | Class II Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.