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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy TK2

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 Class 2 Device Recall Depuy TK2see related information
Date Initiated by FirmOctober 30, 2007
Date PostedJanuary 24, 2008
Recall Status1 Terminated 3 on April 21, 2008
Recall NumberZ-0434-2008
Recall Event ID 45478
510(K)NumberK972629 
Product Classification Hip Screw Trauma Plate - Product Code KTT
ProductDepuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Orthopaedics, Inc., Warsaw, IN 46581
Code Information Lot DHDB73.
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
574-372-7333
Manufacturer Reason
for Recall		Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.
FDA Determined
Cause 2		Process control
ActionConsignees were notified via Urgent Information, Recall Notice(letter) dated 10/30/07 to determine whether they have product on hand and to contact their sales representative to return the product. Dear Doctor letters will be issued to implanting physicians as they are identified.
Quantity in Commerce9
DistributionNationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.
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.
510(K) Database510(K)s with Product Code = KTT
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