← Every firm
Orthofix U.S. LLC FDA Recalls
13 recalls on file across devices, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation devicClass IIJun 10, 2026Unilateral external fixation devices may be incorrectly labe |
| Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation deviceClass IIJun 10, 2026Unilateral external fixation devices may be incorrectly labe |
| Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation deviceClass IIJun 10, 2026Unilateral external fixation devices may be incorrectly labe |
| Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation deviceClass IIJun 10, 2026Unilateral external fixation devices may be incorrectly labe |
| Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti SpaClass IIINov 3, 2025Labeling contains claims that are not consistently present. |
| Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Class IIINov 3, 2025Labeling contains claims that are not consistently present. |
| Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-600Class IIINov 3, 2025Labeling 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 XClass IIINov 3, 2025Labeling 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 33Class IIINov 3, 2025Labeling contains claims that are not consistently present. |
| Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3Class IIINov 3, 2025Labeling contains claims that are not consistently present. |
| Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: Class IISep 19, 2025Polyaxial screws do not meet performance standards. |
| PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SPClass IIJun 24, 2025A 37 mm implant width intervertebral body fusion device has |
| Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: Class IIFeb 20, 2025The product is mislabeled with the incorrect anterior height |