Class IIOngoingZ-0478-2026
Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw
Polyaxial screws do not meet performance standards.
- Thoracolumbosacral Pedicle Screw System
- Process change control
Orthofix U.S. LLCTXNov 19, 2025
Thoracolumbosacral Pedicle Screw System recalls
The FDA has posted 5 enforcement recalls of thoracolumbosacral pedicle screw system devices since 2025, none of them Class I (most serious). Most recent report: Nov 19, 2025.
Class II: 5
Who is recalling these devices
Latest recalls
View all 5 in the recall browser →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
- Thoracolumbosacral Pedicle Screw System
- Labeling Change Control
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
- Thoracolumbosacral Pedicle Screw System
- Labeling Change Control
SPINEART SAAug 20, 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.
- Thoracolumbosacral Pedicle Screw System
- Nonconforming Material/Component
SEASPINE ORTHOPEDICS C…CAJan 1, 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.
- Thoracolumbosacral Pedicle Screw System
- Nonconforming Material/Component
SEASPINE ORTHOPEDICS C…CAJan 1, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Thoracolumbosacral Pedicle Screw System”). Informational only — verify against the FDA before acting.