⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Is Orthofix recalled?

Orthofix recalls - full list & free alerts

Official U.S. agency records list 11 recalls involving Orthofix in the last 12 months, most recently on 2026-07-22. Check each official notice for the exact products, lot codes and dates affected.

Check a lot code, UPC or model number

This is not a guarantee; check the official notice.

Recalls (11)

Orthofix U.S. LLC: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) · 2026-07-22 · Class II
Orthofix U.S. LLC: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) · 2026-07-22 · Class II
Orthofix U.S. LLC: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) · 2026-07-22 · Class II
Orthofix U.S. LLC: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) · 2026-07-22 · Class II
Orthofix U.S. LLC: Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm
Medical DevicesFDA (device) · 2025-12-17 · Class III
Orthofix U.S. LLC: Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿
Medical DevicesFDA (device) · 2025-12-17 · Class III
Orthofix U.S. LLC: Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DE
Medical DevicesFDA (device) · 2025-12-17 · Class III
Orthofix U.S. LLC: Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Sc
Medical DevicesFDA (device) · 2025-12-17 · Class III
Orthofix U.S. LLC: Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9
Medical DevicesFDA (device) · 2025-12-17 · Class III
Orthofix U.S. LLC: Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L
Medical DevicesFDA (device) · 2025-12-17 · Class III
Orthofix U.S. LLC: Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW
Medical DevicesFDA (device) · 2025-11-19 · Class II
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