Orthofix MINIRAIL external fixation devices recalled for incorrect labeling
Orthofix U.S. LLC is recalling 19 units of Orthofix MINIRAIL orthopedic external fixation devices distributed across the US due to incorrect model labeling that could lead to surgical use of the wrong device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device where the labeling error creates a risk of harm (incorrect implant model during surgical procedures) but no injuries or illnesses have been reported in the source text. The potential for patient harm is significant, meeting the High severity threshold for risk-of-harm products without reported adverse events.
Plain-English summary
Orthofix U.S. LLC is recalling Orthofix MINIRAIL, SHORT, LENGTHENER (REF: M103) unilateral external fixation devices due to labeling errors. The devices are incorrectly labeled: Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111.
A total of 19 units with GTIN# 18032568866650 were distributed across the United States to Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, and Wisconsin.
The incorrect labeling creates a risk that surgeons may use the wrong model during orthopedic or trauma procedures. Patients who have received these devices or those who have units in inventory should contact their surgeon or healthcare provider immediately to verify the correct model was implanted or used, and to determine whether corrective action is needed.
Consumers with questions about this recall should contact Orthofix U.S. LLC.
The recalled product
- Product
- Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
- Manufacturer
- Orthofix U.S. LLC
- Hazard
- mis-labeling
- wrong-model-use
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/GTIN# 18032568866650
Distribution
Distributed in 26 states:
- 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
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