Official recall notice
FDA DeviceClass IINotable
FDA Recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation devi
- Recall date
- 2026-07-22
- Brand
- Orthofix U.S. LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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
Product description
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
Affected products
All Lots/GTIN# 18032568866650