United StatesOrthofix MINIRAIL unilateral orthopedic/trauma external fixation devices — STANDARD LENGTHENER M101, SHORT LENGTHENER M103, ARTICULATED MINIRAIL HORIZONTAL AXIS M111, and ARTICULATED MINIRAIL VERTICAL AXIS M122 — are affected. They were recalled because some units were incorrectly labeled (M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111) and were distributed in the United States.
What's being recalled
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Recalling firm: Orthofix U.S. LLC, Lewisville, TX, United States.
How to identify it
All Lots; GTIN# 18032568866636; All Lots/GTIN# 18032568866650 All Lots; GTIN# 18032568866681 All Lots; GTIN# 18032568866711
The 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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)