T2 4.2mmx130mm AO Drill 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-0584-03
- Quantity
- 2344
- 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
1806-4280S T2 4.2mmx130mm AO Drill Bit -- K410511; K419243; K419247; K462304; K462306; K579531; K591907; K591914; K591927; K591937; K637448; K713209; K713210; K723426; K737377; K743644; K770908; K776715; K776716; K776717; K776720; K776721; K796725; K796726; K823858; K823859; K823860; K823861; K834973.
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.