Orthofix recalls unilateral orthopedic external fixators with incorrect labeling that could lead to misuse. Affected models include M101, M103, M111, and M122. No remedy specified in official notice.
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 external fixators due to incorrect labeling that might cause confusion in use. This could lead to improper application if users mix up model numbers.
Incorrect labeling could lead to users applying the wrong model of fixator, which might not fit properly or function as intended. This could cause improper treatment or complications during healing.
Orthopedic patients using these fixators are most at risk if they have the incorrect model labeled on their device. Healthcare providers who apply the fixators may also be affected.
Check the model number on your fixator. The affected models include M101, M103, M111, and M122. All units were sold with the GTIN# 18032568866681.
Look for the model number on your fixator to determine if it is one of the affected models: M101, M103, M111, or M122.
The recall is due to incorrect labeling of the fixators, where some models were labeled with the wrong numbers (e.g., M101 labeled as M103).
The affected models are M101, M103, M111, and M122. All units sold with GTIN# 18032568866681 are included.
The official notice does not specify a remedy, so no action is required beyond checking the model number.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2731-2026 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2731-2026 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.
