Has Orthofix U.S. LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Orthofix U.S. LLC: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-22; Argus observed and indexed it on 2026-07-28.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma ex…

Name: FDA Recall Record — Orthofix U.S. LLC
Creator: Argus HQ
Published: 2026-07-22
License: https://argushq.ai/methodology

Event date: 2026-07-22 00:00:00Z
Observed: 2026-07-28 04:20:58Z
Source ID: Z-2730-2026
Payload hash: b11d80f816064ee00f906ad5…

Summary

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 Status: Ongoing.

Entities

Orthofix U.S. LLC

View source record ↗

Frequently asked questions

Has Orthofix U.S. LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Orthofix U.S. LLC: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-22; Argus observed and indexed it on 2026-07-28.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER  REF: M103, Unilateral orthopedic/trauma ex…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2730-2026

MLA

"Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER  REF: M103, Unilateral orthopedic/trauma ex…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2730-2026.

Chicago

Argus HQ Research. "Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER  REF: M103, Unilateral orthopedic/trauma ex…." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2730-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_orthofix_u_s_llc_z_2730_2026_2026,
  title = {Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER  REF: M103, Unilateral orthopedic/trauma ex…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2730-2026},
  note = {Accessed: July 28, 2026}
}

Informational only. Not legal, financial, or medical advice.