The FDA has posted 7 enforcement recalls of thoracolumbosacral pedicle screw system devices since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mat…
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Polyaxial screws do not meet performance standards.
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
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.