T2 4.2mmx130mm Tri Flat Bit
This recall has been terminated (originally issued February 26, 2003).
- Company
- Stryker Howmedica Osteonics
- Recall Initiated
- January 20, 2003
- Posted
- February 26, 2003
- Terminated
- May 6, 2003
- Recall Number
- Z-0585-03
- Quantity
- 1
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
Distribution
Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
Lot / Code Info
1806-4285S T2 4.2mmx130mm Tri Flat Bit -- K727627; K727628; K727630; K823224; K823225; K824691; K824692; K824693.
Root Cause
Other
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.
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