FDA-Device2026-07-22Class IIMISBRANDING
Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling
What this means
Some Orthofix Articulated Minirail Fixator external fixation devices have been shipped with incorrect labels. Specifically, M101 units were labeled as M103, M103 units were labeled as M101, and M122 units were labeled as M111. Using the wrong component could affect the stability and effectiveness of orthopedic fixation.
- Check the label on any Orthofix Minirail Fixator M111, M101, M103, or M122 devices in your facility.
- Contact Orthofix U.S. LLC to verify the correct component model for any affected devices.
- Do not use a device until the correct labeling 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
32 units
Manufactured in
3451 Plano Pkwy, Lewisville, TX, United States
Products
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2731-2026More Orthofix recalls
- FDA-Device2026-07-22Orthofix Minirail external fixation devices recalled for incorrect labeling
- FDA-Device2026-07-22Orthofix MINIRAIL external fixation devices recalled for incorrect labeling
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