FDA Recall Terminated

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.

Recall: Z-2188-2010 · Initiated June 7, 2010

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Recall

Recall Number
Z-2188-2010
Event Number
56091
Firm
Wright Medical Technology Inc
FEI Number
1043534
Product Code
HRS
Status
Terminated
Root Cause
Packaging process control
Initiated
June 7, 2010
Posted
August 9, 2010
Terminated
November 23, 2011
Address
5677 Airline Rd, Arlington, TN, 38002

Description

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.

Reason

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.

Distribution

Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA

Quantity

8 units