Orthofix U.S Recalls
13 recalls on record · April 2, 2025 to July 22, 2026 · Medical Devices
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 22, 2026Medical DevicesFDA
Orthofix U.S. LLC recalls Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
July 22, 2026Medical DevicesFDA
Orthofix U.S. LLC recalls Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
July 22, 2026Medical DevicesFDA
Orthofix U.S. LLC recalls Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
July 22, 2026Medical DevicesFDA
Orthofix U.S. LLC recalls Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation devic
Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
December 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-600
Hazard: Labeling contains claims that are not consistently present.
December 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spa
Hazard: Labeling contains claims that are not consistently present.
December 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X
Hazard: Labeling contains claims that are not consistently present.
December 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33
Hazard: Labeling contains claims that are not consistently present.
December 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC
Hazard: Labeling contains claims that are not consistently present.
December 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3
Hazard: Labeling contains claims that are not consistently present.
November 19, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
Hazard: Polyaxial screws do not meet performance standards.
September 17, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Hazard: 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. The 37 mm width on the front labels is correct.
April 2, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:
Hazard: 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.