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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 TK2 see related information
Date Initiated by Firm October 30, 2007
Date Posted January 24, 2008
Recall Status1 Terminated 3 on April 21, 2008
Recall Number Z-0435-2008
Recall Event ID 45478
510(K)Number K972629  
Product Classification Hip Screw trauma - Product Code KTT
Product Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581
Code Information Lot DHDB6P.
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
Action Consignees 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 Commerce 4
Distribution Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.
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.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = DEPUY, INC.
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