FDA-Device2026-07-22Class IIMISBRANDING
Orthofix Minirail external fixation devices recalled for incorrect labeling
What this means
Orthofix Minirail orthopedic external fixation devices were shipped with incorrect model labels. Some M101 devices were labeled as M103, M103 devices were labeled as M101, and M122 devices were labeled as M111. This labeling error could cause confusion during surgical planning and device selection.
- If you received or used an Orthofix Minirail device, verify the actual model number matches the label.
- Contact Orthofix U.S. LLC or your supplier immediately if you suspect you have a mislabeled device.
- Do not use a device until the correct model has been confirmed.
The agency's original wording
Hazard
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
Intended for
Adults
Illnesses reported
None reported
Sold states
US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None
Affected count
19 units
Manufactured in
3451 Plano Pkwy, Lewisville, TX, United States
Products
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2730-2026Also reported as
More Orthofix recalls
- FDA-Device2026-07-22Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling
- FDA-Device2026-07-22Orthofix MINIRAIL external fixation devices recalled for incorrect labeling
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