| Class 2 Device Recall Depuy TK2 | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = KTT
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