The FDA has posted 13 enforcement recalls from Orthofix U.S. LLC since 2025, none of them Class I (most serious). Most recent report: Jul 22, 2026.
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
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
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
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
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Polyaxial screws do not meet performance standards.
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.…
Firm name as filed with the FDA: “Orthofix U.S. LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.