FDAFDA · Food and drugs·Recall number Z-2731-2026
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Published July 22, 2026 · Recall initiated: June 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Orthofix U.S. LLC
- Distributor
- 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
- Lot
- All Lots; GTIN# 18032568866681
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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