Z-2188-2010

CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless...

Name: Z-2188-2010 CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless...
Creator: Wright Medical Technology Inc
Published: 2010-06-07
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2010-06-07 / Terminated / root cause: packaging

FDA source

Wright Medical Technology Inc began a recall of 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... on 2010-06-07. The reason FDA records is "One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2188-2010
Status: Terminated
Initiated: 2010-06-07
Posted: 2010-08-09
Terminated: 2011-11-23
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.
Root cause tag: packaging
FDA 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 in commerce: 8 units
Distribution: Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA
Product codes and lots: Item # 40133520 Lot # 0501148499

Product code HRS

K080295Class IICharlotte Claw 3.5Wrightmedicaltechnologyinc / cleared 2008-02-27

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)