FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2188-2010
- Recalling firm
- Wright Medical Technology Inc
- 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.
- Status
- Terminated
- Initiated
- 2010-06-07
- Posted
- 2010-08-09
- Terminated
- 2011-11-23
- 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 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
- 8 units
- Distribution
- Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA
- Lot, serial or model codes
- Item # 40133520 Lot # 0501148499
- 510(k) numbers
- ["K080295"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28