Orthofix
11 federal recalls on file, showing the 10 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Orthofix and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-22FDA-DeviceClass IIOrthofix MINIRAIL fixation devices recalled for incorrect labeling
Orthofix external fixation devices used in orthopedic and trauma surgery have been shipped with incorrect labels. Some M101 models were labeled as M103, M103 models as M101, and M122 models as M111. This labeling error could lead to selection of the wrong device size during surgical procedures.
- 2026-07-22FDA-DeviceClass IIOrthofix Minirail Fixator devices recalled for incorrect labeling
Some Orthofix Articulated Minirail Fixator external fixation devices have been shipped with incorrect labels. Specifically, M101 units were labeled as M103, M103 units were labeled as M101, and M122 units were labeled as M111. Using the wrong component could affect the stability and effectiveness of orthopedic fixation.
- 2026-07-22FDA-DeviceClass IIOrthofix Minirail external fixation devices recalled for incorrect labeling
Orthofix Minirail orthopedic external fixation devices were shipped with incorrect model labels. Some M101 devices were labeled as M103, M103 devices were labeled as M101, and M122 devices were labeled as M111. This labeling error could cause confusion during surgical planning and device selection.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix spine spacer labeling
Orthofix has recalled certain CONSTRUX Mini Ti Spacer System units used in spine surgery because the product labeling contains claims that are not consistently present across all units. This is a labeling discrepancy issue with no reported injuries.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix Forza Ti Spacer labeling
Orthofix U.S. LLC is recalling multiple models of the Forza Ti Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue that may affect product identification and use.
- 2025-12-17FDA-DeviceClass IIIContact Orthofix about FIREBIRD SI screw labeling
Orthofix U.S. LLC is recalling FIREBIRD SI Fusion System screws (multiple sizes, catalog numbers 18-1025SP through 18-2070SP) because the product labeling contains claims that are not consistently present across all units. The issue affects 19,431 screws distributed nationwide and internationally.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix Pillar SA spacer labeling
Orthofix U.S. LLC is recalling multiple models of the Pillar SA PTC Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue affecting the information provided with the device.
- 2025-12-17FDA-DeviceClass IIICheck your FORZA PTC Spacer labeling
Orthofix U.S. LLC is recalling FORZA PTC Spacer System devices because the product labeling contains claims that are not consistently present across all units. This is a labeling issue, not a defect in the device itself.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix spacer system labeling
Orthofix U.S. LLC is recalling multiple models of the CONSTRUX Mini PTC Spacer System because the product labeling contains claims that are not consistently presented across all units. This is a labeling issue only; no injuries have been reported.
- 2025-11-19FDA-DeviceClass IIVirata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045. 5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050. 6. POLYAXIAL SCREW, CC, 6.5mm X 30mm;
Polyaxial screws do not meet performance standards.
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