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Orthofix U.S. LLC: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

Medical DevicesSource: FDA (device) · Date: 2026-07-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Orthofix U.S. LLC
Product
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Reason / 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
Classification
Class II
Status
Ongoing
Distribution / sold at
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
Recall initiated
2026-06-10
Code info
All Lots/GTIN# 18032568866650
Product quantity
19 units
Voluntary mandated
Voluntary: Firm initiated
City
Lewisville
State
TX
Country
United States
Event id
99225
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