Orthofix MINIRAIL External Fixation Device
Orthofix recalls MINIRAIL external fixation devices due to incorrect labeling.
Check your inventory for affected models (Short Lengthener REF M103 and Standard Lengthener M101). Contact Orthofix for return and replacement instructions.
Why it was recalled
Orthofix is recalling certain MINIRAIL unilateral external fixation devices because they were incorrectly labeled. The affected models are the Short Lengthener (REF M103) and Standard Lengthener (Model/Catalog Number M101).
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device | 18032568866636 | Z-2729-2026 |
| Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device | 18032568866681 | Z-2731-2026 |
| Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device | 18032568866711 | Z-2732-2026 |
| Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device | 18032568866650 | Z-2730-2026 |
| Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device | – | – |
| Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device | – | – |
| Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device | – | – |
| Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device | – | – |
Where it was sold
Distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, and Wisconsin.
Official source
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification