# FDA recall Z-2729-2026

> **Orthofix U.S. LLC** · Class II · device recall initiated 2026-06-10.

## Product

Orthofix MINIRAIL, STANDARD LENGTHENER  Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

## 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

## Key facts

- **Recall number:** Z-2729-2026
- **Recalling firm:** Orthofix U.S. LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-10
- **Report date:** 2026-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lewisville, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2729-2026

## Citation

> MORVS. FDA recall Z-2729-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2729-2026. Source: US FDA. Licensed CC0.

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