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
What this means
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.
The agency's original wording
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-2729-2026Want us to check the next one for you?
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