# FDA device recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS  REF: M111, Unilateral orthopedic/trauma external fixation device

> recall · VERIFIED · 2026-06-10

Firm: Orthofix U.S. LLC · Class II · 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

- Company: Orthofix U.S. LLC
- Sector: medical devices
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.