FDAHealthJune 10, 2026
Orthofix U.S. LLC — Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
⚠️ 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
Is this relevant to me?
- Geography
- US, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MD, MI, MO, MS, MT, NC, NY, OH, OR, SC, SD, TX, UT, VA, WA, WI
- Source agency
- FDA
- Category
- Health
- Published
- June 10, 2026
US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None
What's affected?
- Product
- Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
- Brand
- Orthofix U.S. LLC
- Lot code
- s
Additional details
All Lots; GTIN# 18032568866681
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 32 units.
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