Z-3334-2026

CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

Name: Z-3334-2026 CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Creator: Wright Medical Technology, Inc.
Published: 2026-08-18
License: https://open.fda.gov/license/

Wright Medical Technology, Inc. / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-3334-2026
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-10-01
Recalling firm: Wright Medical Technology, Inc.
Product: CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Product code: HRS Plate, Fixation, Bone
Reason for recall: Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.
FDA root cause: Process control
Action: On 8/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: 1) Review the product issue and risks as communicated in this Recall Notice and communicate the issue as appropriate in your organization. 2) Sign and return the enclosed business reply form by email to [email protected] 3) Upon receipt of the completed business reply form, firm will arrange for product return. 4) If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. Inform firm if any of the subject devices have been distributed to other organizations, including contact details, so that firm can inform the recipients appropriately. b. If you are a distributor, notify your affected customers. For questions or concerns, contact the firm at [email protected]
Quantity in commerce: 34
Distribution: US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Product codes and lots: UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026

Product code HRS

K133715Class IICharlotte Claw Plate SystemWrightmedicaltechnologyinc / cleared 2014-02-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)