Date Initiated by Firm |
June 07, 2010 |
Date Posted |
August 09, 2010 |
Recall Status1 |
Terminated 3 on November 23, 2011 |
Recall Number |
Z-2188-2010 |
Recall Event ID |
56091 |
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 TN 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 |
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
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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 = HRS and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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