Class IIOngoingZ-1039-2026
Medicrea International recalls Medicrea
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Medicrea InternationalJan 21, 2026
Intervertebral Fusion Device With Bone Graft, Lumbar recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
Class IIOngoingZ-1038-2026
Medicrea International recalls Medicrea
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Medicrea InternationalJan 21, 2026
Class IIIOngoingZ-0895-2026
Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catal…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0892-2026
Orthofix U.S. LLC recalls Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Cat…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIOngoingZ-0580-2026
Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding mo…
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury.…
Medtronic Sofamor Dane…TNDec 3, 2025
Class IIOngoingZ-2555-2025
Orthofix U.S. LLC recalls PILLAR SA Ti
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box.…
Orthofix U.S. LLCTXSep 17, 2025
Class IIOngoingZ-2554-2025
SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative…
SEASPINE ORTHOPEDICS C…CASep 17, 2025
Class IIOngoingZ-1432-2025
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Orthofix U.S. LLCTXApr 2, 2025
Class IIOngoingZ-1065-2025
Alphatec Spine, Inc. recalls Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) C…
Complaints have been received regarding post-operative implant collapse.
Alphatec Spine, Inc.CAFeb 5, 2025