Recall Z-0241-06 ยท NDH Nail, Fixation, Bone, Metallic
Stryker Howmedica Osteonics Corp.
Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
| Date | Dec 1, 2005 (initiated Nov 22, 2004) |
| Status | Terminated |
| Reason | The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees. |
| Root cause | Other |
| Action | Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt. |
| Quantity | 19 |
| Distribution | The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K034002 | GAMMA3 NAIL SYSTEM Howmedica Osteonics Corp., Jan 15, 2004 |