TemporaryFDAOngoing
Can cause harm that is usually temporary.
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Check the device or its packaging for
All Lots; GTIN# 18032568866681
- Why
- 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
- Distributed
- 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
- Company
- Orthofix U.S. LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2731-2026 · retrieved 14 July 2026
Read the official notice