Recall Z-3334-2026— Wright Medical Technology, Inc.

Name: FDA recall Z-3334-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2026-08-18. It names one FDA 510(k) clearance: K133715. Product: CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System. Reason: 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..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-18
Firm location: arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K133715 — CHARLOTTE CLAW PLATE SYSTEMWrightmedicaltechnologyinc·cleared 2014-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.