Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Orthofix U.S. LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix U.S. LLC · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
- Orthofix MINIRAIL, STANDARD
- LENGTHENER Model/Catalog NumberM101, Unilateral orthopedic/trauma external fixation device
- Lot codes and dates
- All Lots; GTIN# 18032568866636;
- Amount recalled
- 48 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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