- Recalling firm
- Wright Medical Technology, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
- Units affected
- 34
- Distribution pattern
- US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
- Firm location
- arlington, TN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3334-2026
- Recall initiated
- August 18, 2026
- FDA classification date
- September 30, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99651
- Last updated on HTM Vibe
- October 13, 2026
