The FDA has posted 9 enforcement recalls from Orthofix U.S. LLC since 2025, none of them Class I (most serious). Most recent report: Dec 17, 2025.
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.…
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.
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.