Recall Z-1351-2009 ยท JDS Nail, Fixation, Bone
Stryker Howmedica Osteonics Corp.
Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
| Date | Jun 1, 2009 (initiated Mar 2, 2009) |
| Status | Terminated |
| Reason | Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails. |
| Root cause | Labeling design |
| Action | Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past. |
| Quantity | 18232 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.