Blue Ortho Recalls Predict+ Software for Lack of FDA Clearance
Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 for a lack of pre-market clearance, which is a regulatory compliance issue rather than a direct physical hazard. No injuries or illnesses are reported, and the agency classification is Class II, fitting the criteria for a moderate severity recall involving labeling or regulatory errors.
Plain-English summary
Blue Ortho is recalling 136 units of Predict+ software, version v1.3. Predict+ is a data-driven clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery.
The recall was initiated because the software lacks pre-market clearance or approval from the U.S. Food and Drug Administration. The agency has classified this recall as Class II.
The affected software was distributed nationwide in the United States. Consumers and healthcare providers should stop using the software and contact Blue Ortho for further instructions.
The recalled product
- Product
- Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
- Manufacturer
- Blue Ortho
- Category
- Medical Device — Software
- Affected units
- 136
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)
- Software version v1.3
Distribution
Distributed nationwide across the United States.
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