Skip to main content

fda_recall · device_recall · high

Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ort…

Event date
2026-07-22 00:00:00Z
Observed
2026-07-28 04:20:57Z
Source ID
Z-2731-2026
Payload hash
8587396aeeef2bcea2a2c3de…

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

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 ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS  REF: M111, Unilateral ort…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2731-2026
MLA
"Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS  REF: M111, Unilateral ort…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2731-2026.
Chicago
Argus HQ Research. "Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS  REF: M111, Unilateral ort…." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2731-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_orthofix_u_s_llc_z_2731_2026_2026,
  title = {Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS  REF: M111, Unilateral ort…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-orthofix-u-s-llc-z-2731-2026},
  note = {Accessed: July 28, 2026}
}

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

Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ort… · Argus HQ