Recall Z-2731-2026— Orthofix U.S. LLC

Name: FDA recall Z-2731-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Class II · Ongoing

Class II FDA medical device recall by Orthofix U.S. LLC, initiated 2026-06-10. It names one FDA 510(k) clearance: K113770. Product: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, 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

510(k) clearances named in this recall

1 on FDA's record

K113770 — ORTHOFIX GALAXY FIXATION SYSTEMOrthofix Srl·cleared 2012-09-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, 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.