| | Class 2 Recall
CLAW HEX SCREWS |  |
| Date Posted |
August 09, 2010 |
| Recall Number |
Z-2188-2010 |
| 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
|
Reason for
Recall |
One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.
|
| 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 |
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