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U.S. Department of Health and Human Services

Class 2 Device Recall CLAW HEX SCREWS

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 Class 2 Recall
CLAW HEX SCREWS
see related information
Date Posted August 09, 2010
Recall Status1 Terminated on November 23, 2011
Recall Number Z-2188-2010
Recall Event ID 56091
Premarket Notification
510(K) Number
K080295 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product CLAW® HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless Steel Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava® 3.5MM - Non-Sterile. Implantation: used in Food and Ankle surgeries.
Code Information Item # 40133520 Lot # 0501148499
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002
For Additional Information Contact Debby Daurer
901-387-9971
Manufacturer Reason
for Recall
One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action The firm initiated their recall to their sales representatives (distributors) via telephone on 06/07/2010 and followed with a letter dated June 15, 2010 sent via Fed Ex on 06/28/2010. The hospital involved was also notified by letter on 06/29/2010. The letter described the product, the problem,and the action to be taken by the customers. The customers were instructed to immediately return any affected product to Wright as soon as possible, and to complete an attached response form confirming receipt of the notice and return a copy by fax to 901-867-7401. Customers may contact customer service for return instructions and replacement inventory at 800-238-7117. If you have any questions regarding this matter, contact Debby Daurer at 800-874-5630.
Quantity in Commerce 8 units
Distribution Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA
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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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