Quick Facts at a Glance
- Recall Date
- June 10, 2026
- Hazard Level
- HIGH
- Brand
- Orthofix U.S.
- Geographic Scope
- Nationwide (50 states)
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Orthofix U.S.
- Model numbers
- All Lots, GTIN# 18032568866681
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 10, 2026
Reported by FDA DEVICE
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
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Full Description
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device. Reason: 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. Classification: Class II. Quantity: 32 units. Distribution: 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
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Safety Guide
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