Orthofix U.S. LLC
Medical device manufacturer in Lewisville, TX.
0510(k) clearances
0PMA approvals
13recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2732-2026 Class II | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |
| Z-2731-2026 Class II | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |
| Z-2730-2026 Class II | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |
| Z-2729-2026 Class II | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |
| Z-0896-2026 Class III | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer…Labeling contains claims that are not consistently present. | 11/03/2025Open, Classified |
| Z-0895-2026 Class III | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog…Labeling contains claims that are not consistently present. | 11/03/2025Open, Classified |
| Z-0894-2026 Class III | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System…Labeling contains claims that are not consistently present. | 11/03/2025Open, Classified |
| Z-0893-2026 Class III | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System…Labeling contains claims that are not consistently present. | 11/03/2025Open, Classified |
| Z-0892-2026 Class III | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System…Labeling contains claims that are not consistently present. | 11/03/2025Open, Classified |
| Z-0891-2026 Class III | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer…Labeling contains claims that are not consistently present. | 11/03/2025Open, Classified |
| Z-0478-2026 Class II | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The…Polyaxial screws do not meet performance standards. | 09/19/2025Open, Classified |
| Z-2555-2025 Class II | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SPA 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of… | 06/24/2025Open, Classified |
| Z-1432-2025 Class II | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile…The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant… | 02/20/2025Open, Classified |