Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2731-2026·Announced 2026-07-22

Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling

Orthofix U.S. LLC is recalling Articulated Minirail Fixator external fixation devices due to incorrect model labeling. Three models were mislabeled: M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving labeling errors on medical devices. The source text does not report any illnesses, injuries, or hospitalizations. The hazard is a labeling/identification issue that creates risk of use error, which falls under minor labeling errors typical of a Moderate classification.

Plain-English summary

Orthofix U.S. LLC is recalling the Articulated Minirail Fixator Horizontal Axis (REF: M111), a unilateral orthopedic/trauma external fixation device. The devices in this recall were incorrectly labeled with mismatched model numbers. Specifically, Minirail M101 units were labeled as M103, Minirail M103 units were labeled as M101, and Minirail M122 units were labeled as M111.

A total of 32 units have been recalled and distributed across 27 U.S. states, including Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, and Wisconsin.

Incorrect labeling could lead to selection and use of the wrong external fixation device for intended surgical procedures. Patients and healthcare providers who have received or used these devices should verify the actual model number on the device against documentation. Contact Orthofix U.S. LLC or your healthcare provider if you have questions about whether a device is affected by this recall.

The recalled product

Product: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Manufacturer: Orthofix U.S. LLC
Category: Medical Device — Orthopedic/Trauma External Fixation
Hazard: mis-labeling
use-error
Affected units: 32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

All Lots
GTIN# 18032568866681

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 4 recalled by Orthofix U.S. LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Orthofix U.S. LLC

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