Orthofix recalls
4 federal recalls on file, showing the 3 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Orthofix and put it in plain English.
Recent recalls
Orthofix MiniRail devices recalled for mislabelingOrthofix is recalling four MiniRail external fixation devices, 161 units in total, because some units may carry the wrong model number. The M101 and M103 labels may be swapped, and some M122 units may be labeled M111. No injuries have been reported.
ModerateFDAJul 22, 20264 products
- Orthofix CONSTRUX, FORZA and Pillar implants recalled for labeling issues
Orthofix is recalling six spinal implant products, including CONSTRUX, FORZA, Pillar, FIREBIRD and Forza Ti spacer and fusion systems. The FDA says the product labeling contains claims that are not consistently present. No injuries have been reported, and the FDA has not specified a remedy.
FDADec 17, 20256 products
- Virata 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.
FDANov 19, 2025