Class IIOngoingZ-0478-2026
Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw
Polyaxial screws do not meet performance standards.
Orthofix U.S. LLCTXNov 19, 2025
Thoracolumbosacral Pedicle Screw System recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–5 of 5 recalls
Class IIOngoingZ-2280-2025
SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model…
Cannulated fenestrated polyaxial screws may be incorrectly labeled
SPINEART SAAug 20, 2025
Class IIOngoingZ-2279-2025
SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model…
Cannulated fenestrated polyaxial screws may be incorrectly labeled
SPINEART SAAug 20, 2025
Class IIOngoingZ-0752-2025
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
SEASPINE ORTHOPEDICS C…CAJan 1, 2025
Class IIOngoingZ-0751-2025
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
SEASPINE ORTHOPEDICS C…CAJan 1, 2025