Gamma Drill 5.5x300mm
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-0579-03
- Quantity
- 5062
- 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
1214-5300S -- Gamma Drill 5.5x300mm -- K400056; K412682; K423453; K451275; K467231; K469197; K494341; K494342; K508650; K516457; K526734; K533284; K542636; K548132; K553788; K553789; K562650; K562654; K573121; K573122; K579936; K579937; K579938; K619518; K622108; K622109; K637404; K641097; K653378; K665203; K665204; K665205; K678519; K679127; K713867; K713868; K714918; K714919; K714920; K714921; K714922; K714923; K714924; K714925; K714926; K717459; K717462; K721328; K724574; K732012; K732013; K733474; K748814; K748817; K753097; K753098; K774660; K775180; K784772; K784774; K784775; K821925; K829527; K829529; K834976; K957002.
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.