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Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individua
Recalled October 30, 2024 · FDA recall Z-0209-2025 · Blue Ortho
Hazard
Predict+ is being recalled for lack of pre-market clearance/approval. · FDA Class II
Units
136 software units
Sold at
US Nationwide distribution.
Description
Predict+ is being recalled for lack of pre-market clearance/approval.
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(s)
Blue Ortho
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →