Orthofix
10 federal recalls on file. 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
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
- 2026-07-22FDA-DeviceClass IIOrthofix Minirail Fixator devices recalled for incorrect labeling
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
- 2026-07-22FDA-DeviceClass IIOrthofix Minirail external fixation devices recalled for incorrect labeling
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
- 2025-12-17FDA-DeviceClass IIICheck Orthofix spine spacer labeling
Labeling contains claims that are not consistently present.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix Forza Ti Spacer labeling
Labeling contains claims that are not consistently present.
- 2025-12-17FDA-DeviceClass IIIContact Orthofix about FIREBIRD SI screw labeling
Labeling contains claims that are not consistently present.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix Pillar SA spacer labeling
Labeling contains claims that are not consistently present.
- 2025-12-17FDA-DeviceClass IIICheck your FORZA PTC Spacer labeling
Labeling contains claims that are not consistently present.
- 2025-12-17FDA-DeviceClass IIICheck Orthofix spacer system labeling
Labeling contains claims that are not consistently present.
- 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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