Orthofix recalls MINIRAIL Standard Lengthener Model M101 due to mislabeling risks incorrect use. Check your device's model number against the recall list.
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 MINIRAIL Standard Lengthener Model M101 because it may be mislabeled as a different model. This could lead to incorrect use if the device is not properly matched to the patient's needs.
The device may be incorrectly labeled, meaning it could be used as a different model. This might cause improper application or adjustment, potentially leading to complications if the device is not correctly matched to the patient's needs.
Patients using Orthofix MINIRAIL Standard Lengthener Model M101 devices are affected. Those with the device mislabeled as another model are at higher risk of incorrect use.
Check the model number on your device. The recalled model is M101, which may be labeled as M103, M122, or M111. The product was sold with GTIN# 18032568866636.
Look for the model number on your device to confirm if it matches the recalled M101 or mislabeled versions.
The recall is for mislabeling, not an immediate injury risk. However, incorrect use could lead to complications if the device is not properly matched to the patient's needs.
Check the model number on your device. The recalled model is M101, which may be labeled as M103, M122, or M111. The product was sold with GTIN# 18032568866636.
No, but you should check the model number to ensure it's not mislabeled. If it is, contact Orthofix for guidance.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2729-2026 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2729-2026 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.
