This is part of a larger recall. The most authoritative record is FDA-Device / Z-2730-2026.
Orthofix MINIRAIL external fixation devices recalled for incorrect model labeling
Orthofix MINIRAIL external fixation devices recalled for labeling mix-up
Orthofix external fixation devices were shipped with incorrect model labels. Some M101 units were labeled as M103, M103 units were labeled as M101, and M122 units were labeled as M111. This labeling error could lead to incorrect device selection or installation during orthopedic procedures.
- If you received or used an Orthofix MINIRAIL device, verify the actual model number on the device itself matches the label.
- Contact your Orthofix distributor or Orthofix U.S. LLC if your device label does not match the model.
- Do not use a device until you have confirmed the label matches the actual model.
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2729-2026More Orthofix U.S. LLC recalls
- FDA-Device2026-07-22Orthofix MINIRAIL external fixation devices recalled for incorrect labeling
- FDA-Device2026-07-22Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling
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