FDA action counts
| Total FDA actions | 4 |
|---|---|
| Warning letters | 0 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | July 22, 2026 |
Enforcement history
On 2026-07-22, Argus HQ recorded an FDA recall for Orthofix U.S. LLC, rated "high" severity in Argus HQ's classification: Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ort…. On 2026-07-22, Argus HQ recorded an FDA recall for Orthofix U.S. LLC, rated "high" severity in Argus HQ's classification: Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral or…. On 2026-07-22, Argus HQ recorded an FDA recall for Orthofix U.S. LLC, rated "high" severity in Argus HQ's classification: Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral o…. On 2026-07-22, Argus HQ recorded an FDA recall for Orthofix U.S. LLC, rated "high" severity in Argus HQ's classification: Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma ex…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Orthofix U.S. LLC has 4 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Frequently asked questions
- Does Argus HQ track new FDA actions for Orthofix U.S. LLC automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Orthofix U.S. LLC is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Orthofix U.S. LLC?
- 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Orthofix U.S. LLC?
- July 22, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has Orthofix U.S. LLC had product recalls?
- Yes, 4 recalls on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma ex… →
- Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral o… →
- Orthofix U.S. LLC — Class II recall: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral or… →
- Orthofix U.S. LLC — Class II recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ort… →
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jul 22, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Actions Against Orthofix U.S. LLC. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/orthofix-u-s-llc
"FDA Actions Against Orthofix U.S. LLC." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/orthofix-u-s-llc.
Argus HQ Research. "FDA Actions Against Orthofix U.S. LLC." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/company/orthofix-u-s-llc.
@misc{argushq_argushq_ai_company_orthofix_u_s_llc_2026,
title = {FDA Actions Against Orthofix U.S. LLC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/orthofix-u-s-llc},
note = {Accessed: July 28, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗