FDA Device

Gamma Drill 5.5x300mm

Hazard

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

What You Should Do

Remedy

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.

Products

Gamma Drill 5.5x300mm
Brand
Stryker Howmedica Osteonics
UPC
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.

Units Affected

5062