Orthofix recalls Minirail M122 unilateral orthopedic fixators due to incorrect labeling. Check if your device has wrong model numbers like M101 labeled as M103.
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 its Minirail M122 unilateral orthopedic fixators because they may be incorrectly labeled. This could lead to confusion about which model you have, potentially causing improper use or safety issues.
Incorrect labeling means the device might be misidentified as a different model. This could lead to improper use if the user thinks they have a different fixator than what they actually have.
Patients using Orthofix Minirail M122 fixators for orthopedic or trauma treatment. Those with the wrong model number labels are most at risk.
Check the label on your device for model numbers. The recalled product is labeled as M122 but may show M101 or M103 instead. All lots of this fixator are affected.
Look for model numbers on the device label; the recalled product may show M101 labeled as M103 or M103 labeled as M101 instead of M122.
The recall is due to incorrect labeling, not immediate danger. However, using the wrong model could lead to improper application or safety issues.
Check the label for model numbers. If it shows M101 labeled as M103 or M103 labeled as M101 instead of M122, it is affected.
No, the recall does not require stopping use. The issue is labeling, not a safety hazard that requires immediate action.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2732-2026 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2732-2026 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.
