Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individu…

Recall date

August 30, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0209-2025

FDA classification

Class II

Brand / firm

Blue Ortho

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery