medical Class II Updated 2024-10-30

Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool th

Recalled 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


Hazard / Issue

Predict+ is being recalled for lack of pre-market clearance/approval.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version v1.3
View official government recall

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