Orthofix recalls MINIRAIL unilateral external fixation devices with incorrect labeling (M101 labeled as M103, etc.). Affected units have GTIN# 18032568866650. No immediate action needed but verify labeling.
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
Orthofix is recalling certain MINIRAIL external fixation devices because they may be incorrectly labeled. This could lead to confusion about which model you have, potentially causing improper use. The recall does not require immediate action but requires checking the labeling.
The devices may be mislabeled, meaning the model number on the device (e.g., M101) might not match what it's labeled as (e.g., M103). This could lead to confusion about which device you have, but it does not cause injury or malfunction in normal use.
Orthopedic patients using Orthofix MINIRAIL devices with GTIN# 18032565866650 are most at risk if they have the wrong model. Patients should check their device labels carefully.
Check the device label for the model number. Affected units have GTIN# 18032568866650. The device may be labeled as M101 but actually be M103, or vice versa.
Look for the model number on the device label to confirm it matches the correct labeling.
No, the recall does not require stopping use. Check the labeling to ensure you have the correct model.
The affected units have GTIN# 18032568866650.
Check the device label for the model number. If it shows M101 but the device is actually M103, or vice versa, it may be mislabeled.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2730-2026 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2730-2026 from Orthofix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
