Gamma Drill Dia. 4.2x300mm
FDA device recall Z-0581-03 · posted 2003-02-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 12
- Distribution
- Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
- Date initiated
- 2003-01-20
- Date posted
- 2003-02-26
- Date terminated
- 2003-05-06
- Location
- Mahwah, NJ
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