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U.S. Department of Health and Human Services

Class 2 Device Recall Odyssey Femoral Holder/Driver

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  Class 2 Device Recall Odyssey Femoral Holder/Driver see related information
Date Initiated by Firm October 04, 2007
Date Posted November 27, 2007
Recall Status1 Terminated 3 on July 22, 2009
Recall Number Z-0290-2008
Recall Event ID 45462
Product Classification Femoral Holder/Driver - Product Code HWR
Product Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
Code Information Lot Numbers: 047367193, 067380510, and 077414021
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Road
Arlington TN 38002-0100
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall		 Breakage: breaking of the connecting foot that is on the distal surface of the instrument
FDA Determined
Cause 2		 Device Design
Action The firm notified their distributors of the recall on October 4, 2007, with an Urgent Medical Device Recall letter explaining the problem and requesting return of the product from their inventory and from their consignees. The hospitals were notified of the recall on October 4, 2007 using the same Urgent Device Recall Letter.
Quantity in Commerce 66 units
Distribution Worldwide-USA and Australia
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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