Orthofix MINIRAIL external fixation devices recalled for incorrect model labeling
Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.
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: FDA Class II recall with a labeling defect that could lead to use of incorrect device specifications. No reported illnesses or injuries are documented in the source text. The hazard is primarily a risk of misuse due to mislabeling rather than an inherent device malfunction.
Plain-English summary
Orthofix U.S. LLC is recalling Orthofix MINIRAIL, STANDARD LENGTHENER external fixation devices (Model M101, GTIN# 18032568866636) due to incorrect model labeling. The recalled devices may be labeled as Model M103, Model M103 devices may be labeled as Model M101, and Model M122 devices may be labeled as Model M111.
These unilateral orthopedic/trauma external fixation devices are used for bone lengthening and trauma repair. Incorrect labeling could result in a device being used that does not match the intended clinical specifications, potentially compromising treatment outcomes.
The recall affects 48 units distributed across multiple U.S. states: 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.
Customers and healthcare facilities who have received these devices should verify the actual device model against the label and contact Orthofix U.S. LLC to determine if their inventory is affected and to obtain the correct labeling or replacement devices as needed.
The recalled product
- Product
- Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
- Manufacturer
- Orthofix U.S. LLC
- Affected units
- 48
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# 18032568866636
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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