Recall Z-2732-2026— Orthofix U.S. LLC
Class II · Ongoing
Class II FDA medical device recall by Orthofix U.S. LLC, initiated 2026-06-10. Product: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device. Reason: 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.
- Recalling firm
- Orthofix U.S. LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-10
- Firm location
- Lewisville, TX, United States
Product description
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.