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Wright Medical Technology, Inc.: CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

Medical DevicesSource: FDA (device) · Date: 2026-10-07

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Wright Medical Technology, Inc.
Product
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Recall initiated
2026-08-18
Code info
UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
Product quantity
34
Voluntary mandated
Voluntary: Firm initiated
City
arlington
State
TN
Country
United States
Event id
99651
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