---
title: "Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral ... — FDA record Z-2732-2026 | Is It on Recall"
description: "Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was lab"
url: https://isitonrecall.com/recall/fda-device-z-2732-2026-orthofix-minirail-articulated-fixator-vertical-axis-ref-m122-unilateral-orthopedic-trauma-external-f/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device — FDA record Z-2732-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 10, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, 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
- **Recalling firm**: Orthofix U.S. LLC
- **Quantity**: 62 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2732-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2732-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | All Lots; GTIN# 18032568866711 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Montana](https://isitonrecall.com/state/montana/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Jul 22, 2026
- **Recall initiation date**: Jun 10, 2026
- **Center classification date**: Jul 14, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2732-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Orthofix U.S. LLC records](https://isitonrecall.com/brand/orthofix-u-s-llc/)