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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated Hex Screwdriver

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 Class 2 Recall
Cannulated Hex Screwdriver
see related information
Date Posted April 28, 2009
Recall Status1 Terminated on February 03, 2010
Recall Number Z-1208-2009
Recall Event ID 51431
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Code Information Lot numbers: 019598209, 038504328, 058486628, 058507733, 058516752, 067422530, 088538652, 098538652, 107439501, 107442247, 117442247, 0712180, S0701050
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall
The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.
FDA Determined
Cause 2
DESIGN: Process Design
Action Wright Medical notified their distributors of the recall on 03/11/2009 by letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals and surgeons were notified of the recall also on 03/11/2009. All letters were delivered by Fed Ex.
Quantity in Commerce 682 devices
Distribution Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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