Orthofix U.S. LLC

9 FDA enforcement actions

9 Total Recalls

0 Class I

3 Class II

6 Class III

Firm Details

Product Types: device
States: TX

All Recalls

Class III: Low Risk 11/03/2025 device

Labeling contains claims that are not consistently present.
Class III: Low Risk 11/03/2025 device

Labeling contains claims that are not consistently present.
Class III: Low Risk 11/03/2025 device

Labeling contains claims that are not consistently present.
Class III: Low Risk 11/03/2025 device

Labeling contains claims that are not consistently present.
Class III: Low Risk 11/03/2025 device

Labeling contains claims that are not consistently present.
Class III: Low Risk 11/03/2025 device

Labeling contains claims that are not consistently present.
Class II: Risk 09/19/2025 device

Polyaxial screws do not meet performance standards.
Class II: Risk 06/24/2025 device

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 front labels is correct.
Class II: Risk 02/20/2025 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.