Orthofix U S recalls
Orthofix U S appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2025-04-02 to 2026-07-22 |
| By agency | FDA Device (13) |
| By classification | Class II (7), Class III (6) |
| By status | ongoing (13) |
| Distribution named in notices | AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MD, MI, MO, MS, MT, NC, NY, OH, OR, SC, SD, TX, US, UT, VA, WA, WI |
Recalls
- Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S
Reason: 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 - Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S
Reason: 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 - Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S
Reason: 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 - Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S
Reason: 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 - Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿,…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Reason: Labeling contains claims that are not consistently present. - 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, 7DEG…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Reason: Labeling contains claims that are not consistently present. - Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Scr…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Reason: Labeling contains claims that are not consistently present. - Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L,…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Reason: Labeling contains claims that are not consistently present. - Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Reason: Labeling contains claims that are not consistently present. - Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Reason: Labeling contains claims that are not consistently present. - Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System
FDA Device · Class II · 2025-11-19 · Orthofix U S
Reason: Polyaxial screws do not meet performance standards. - PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
FDA Device · Class II · 2025-09-17 · Orthofix U S
Reason: A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the fron… - Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33m…
FDA Device · Class II · 2025-04-02 · Orthofix U S
Reason: The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.