Ortho Solutions Recalls Mislabelled Oxford AFN End Caps
Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps due to material mislabeling. The affected devices were distributed to Maryland, New York, and Pennsylvania.
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: The recall is classified as FDA Class II, and the source text identifies the issue as 'material mislabeling' without reporting any illnesses or injuries. This aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps. These medical devices are circular disks with a small threaded shaft designed to be screwed to the distal end of a nail. The recall is being conducted because of a material mislabeling issue with the product.
The affected end caps were distributed in the United States to Maryland, New York, and Pennsylvania. The recall covers multiple item codes and lot numbers manufactured between March 2017 and October 2019.
Consumers and healthcare providers should stop using the affected end caps and contact Ortho Solutions Inc for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
- Manufacturer
- Ortho Solutions Inc
- Hazard
- Affected units
- 277
Distribution
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