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U.S. Department of Health and Human Services

Class 2 Device Recall T2

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 Class 2 Device Recall T2see related information
Date Initiated by FirmJanuary 20, 2003
Date PostedFebruary 26, 2003
Recall Status1 Terminated 3 on May 06, 2003
Recall NumberZ-0584-03
Recall Event ID 25585
Product Classification Bit, Drill - Product Code HTW
ProductT2 4.2mmx130mm AO Drill Bit
Code Information 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.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information ContactThomas 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
ActionHowmedica 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 Commerce2344
DistributionProduct was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
Total Product Life CycleTPLC 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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