Paragon 28 Recalls Custom Foot Implant Due to Material Defect
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which is typically a score of 1 or 2. The hazard involves a material defect (reduced ductility) without reported injuries, fitting the Moderate category for low-risk issues.
Plain-English summary
Paragon 28, Inc. is recalling one unit of the Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R. The device is a foot implant with Lot Number AOCIA6123.
The recall was initiated because the device was found to have an elevated oxygen level in excess of the allowable limit. According to the source, elevated oxygen levels may contribute to reduced material ductility.
The device was distributed in the state of Montana. The source text does not specify further consumer actions or report any injuries or illnesses.
The recalled product
- Product
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Manufacturer
- Paragon 28, Inc.
- Hazard
- Affected units
- 1
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)
- Lot Number AOCIA6123
Distribution
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