FDA-Device2026-07-22Class IIMISBRANDING
Orthofix MINIRAIL external fixation devices recalled for incorrect labeling
Orthofix MINIRAIL fixation devices recalled for incorrect labeling
Orthofix external fixation devices used in orthopedic and trauma surgery have been shipped with incorrect labels. Some M101 models were labeled as M103, M103 models as M101, and M122 models as M111. This labeling error could lead to selection of the wrong device size during surgical procedures.
- Verify the actual model number of any Orthofix MINIRAIL device against its physical markings before use
- Contact Orthofix or your supplier if you have devices from the affected lots
- Do not rely solely on the package label to confirm device size
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
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
62 units
Manufactured in
3451 Plano Pkwy, Lewisville, TX, United States
Products
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2732-2026More Orthofix U.S. LLC 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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