Class II

Medical Device Recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

Orthofix U.S. LLC · June 10, 2026

Reason for Recall

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

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

States Affected

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

Quantity Affected

19 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2730-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Orthofix U.S. LLC Medical Device Recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device | SafeCheck