FDA-Device2026-10-07Class IIPROCESSING DEFECT

Wright Medical CHARLOTTE CLAW Screws recalled for defective threads preventing secure plate engagement

OTHERNationwide distributionMedical devices

What this means

Wright Medical manufactured CHARLOTTE CLAW Screws (REF: 40122716) with missing threads on the screwheads. These screws are designed to work with the CLAW II Polyaxial Compression Plating System for foot surgery. If used, the missing threads could prevent the screw from securing properly to the plate, potentially requiring surgery to be extended or alternative procedures performed.

  • If you are a surgeon or surgical facility with lot 1826666 distributed between August 18, 2025 and April 9, 2026, do not use these screws.
  • Contact Wright Medical Technology for instructions on replacement or return of affected screws.
  • Check any surgical inventory against the lot number (1826666) and UDI-DI (00840420109705).
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Affected count
34
Manufactured in
11500 memphis arlington rd, arlington, TN, United States
Products
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3334-2026

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