Orthofix MINIRAIL External Fixation Devices Incorrectly Labeled
Orthofix MINIRAIL unilateral external fixation devices may be labeled with incorrect model numbers. Three model variants (M101, M103, M122) were mislabeled during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling discrepancy on a medical device. The source text does not report any illnesses, injuries, or hospitalizations. Labeling errors that could be corrected with verification fall into the Moderate category.
Plain-English summary
Orthofix U.S. LLC is recalling Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS unilateral external fixation devices (REF: M122) due to incorrect labeling. Affected devices include units where Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111.
A total of 62 units have been distributed across the United States, including 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. All lots are affected, with GTIN# 18032568866711.
Patients and healthcare providers should verify the actual model number of their device against the manufacturer's documentation. Anyone who has received or used one of these devices should contact Orthofix U.S. LLC or their healthcare provider for clarification or corrective action.
The recalled product
- Product
- Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
- Manufacturer
- Orthofix U.S. LLC
- Hazard
- Affected units
- 62
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 (2)
- All Lots
- GTIN# 18032568866711
Distribution
Part of a larger recall action
This product is one of 4 recalled by Orthofix U.S. LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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