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

Orthofix recalls - full list & free alerts

11 official U.S. recalls involving Orthofix in the last 12 months, most recently on 2026-07-22.

Check a lot code or UPC for Orthofix · Recall guides

Get alerts for Orthofix

Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.

Full list (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