Class IIOngoingZ-3226-2026
SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head
The proximal thread depth of the spinal device is out of design specification.
SEASPINE ORTHOPEDICS C…CASep 30, 2026
Thoracolumbosacral Pedicle Screw System recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
Class IIOngoingZ-2859-2026
Innovasis, Inc recalls Anti-Torque
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…
Innovasis, IncUTAug 12, 2026
Class IIOngoingZ-2762-2026
SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
SEASPINE ORTHOPEDICS C…CAJul 29, 2026