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FDAFDA · Food and drugs·Recall number Z-3334-2026

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

Published October 7, 2026 · Recall initiated: August 18, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Wright Medical Technology, Inc.
Distributor
US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Lot
UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
Risk classification
Class II
Area (FDA)
device
Country
United States

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Questions about this recall

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

Yes. FDA published recall Z-3334-2026 on October 7, 2026. Reported hazard: 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.

What should I do if I have this product?

Voluntary: Firm initiated · Letter

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