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U.S. Department of Health and Human Services

Class 2 Device Recall Gamma

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  Class 2 Device Recall Gamma see related information
Date Initiated by Firm January 20, 2003
Date Posted February 26, 2003
Recall Status1 Terminated 3 on May 06, 2003
Recall Number Z-0579-03
Recall Event ID 25585
Product Classification Bit, Drill - Product Code HTW
Product Gamma Drill 5.5x300mm
Code Information 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.  
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Thomas Grzeskowiak
201-831-5495
Manufacturer Reason
for Recall		 Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 5062
Distribution Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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