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.
FDA Recall Z-2188-2010 · Posted 2010-08-09
Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeHRS
Date Initiated2010-06-07
Date Terminated2011-11-23
Product Quantity8 units
Reason for Recall
One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.