Device recall
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
- Recall number
- Z-3334-2026
- Event id
- 99651
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Wright Medical Technology, Inc.
- Report date
- Oct 7, 2026
- Posted
- Oct 1, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Sep 30, 2026
- Product code
- HRS
- Device type
- Plate, Fixation, Bone
- 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.
- Root cause
- Process control
- Quantity
- 34
- Code info
- UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
- Distribution
- US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K133715
- Location
- arlington, TN, United States