Z-3334-2026 Class II Ongoing
FDA device recall Z-3334-2026 was initiated by Wright Medical Technology, Inc. on Aug 18, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 34.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 18, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34
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.
Distribution Pattern
US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Code Information
UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3334-2026
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026