Recall Z-0580-03 ยท HTW Bit, Drill
Stryker Howmedica Osteonics
Gamma AO Drill 5.5x300mm
| Date | Feb 26, 2003 (initiated Jan 20, 2003) |
| Status | Terminated |
| Reason | Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility. |
| Root cause | Other |
| Action | Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts. |
| Quantity | 53 |
| Distribution | Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.