Orthofix U.S. LLC recalls

All Orthofix U.S. LLC recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (13).

13 recalls published between April 2, 2025 and July 22, 2026. Most common issues: mislabeling (1).

• Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Orthofix MINIRAIL, SHORT, LENGTHENER recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Orthofix MINIRAIL, STANDARD LENGTHENER Model recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer… recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System… recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer… recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal… recall
  FDA November 19, 2025 · Orthofix U.S. LLC · Class II
• PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees recall
  FDA September 17, 2025 · Orthofix U.S. LLC · Class II
• Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal… recall
  FDA April 2, 2025 · Orthofix U.S. LLC · Class II