Recall Z-2188-2010 ยท HRS Plate, Fixation, Bone
Wright Medical Technology Inc
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.
| Date | Aug 9, 2010 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws. |
| Root cause | 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 servi |
| Quantity | 8 units |
| Distribution | Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080295 | CHARLOTTE CLAW 3.5 Wrightmedicaltechnologyinc, Feb 27, 2008 |