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Medium risk Medical DevicesClass II

Orthofix MINIRAIL M101 Recall

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

Updated June 10, 2026

Orthofix MINIRAIL external fixation devices were shipped with incorrect model labels. The M101 was labeled as M103, the M103 was labeled as M101, and the M122 was labeled as M111. Using the wrong model could lead to improper surgical application.

Is the Orthofix U.S. LLC recalled? Yes. This product was recalled by FDA on June 10, 2026. Details below.

What is recalled

Orthofix MINIRAIL, STANDARD LENGTHENER unilateral orthopedic/trauma external fixation devices, Model M101 (labeled as M103), Model M103 (labeled as M101), and Model M122 (labeled as M111).

Am I affected

You're affected if you have an Orthofix MINIRAIL external fixation device and the label on your device shows a model number that does not match the intended model you received from your supplier.

What to do right now

Contact Orthofix U.S. LLC to verify the correct model number of your device and confirm the label is accurate before use. Do not proceed with surgery if there is any doubt about which model you have.

The hazard

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

Brands affected

Orthofix U.S. LLC
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2729-2026
Classification
Class II
Recalled
June 10, 2026
Read the official notice

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