Class II
Medical Device Recall: Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Blue Ortho · August 30, 2024
Reason for Recall
Predict+ is being recalled for lack of pre-market clearance/approval.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
136 software units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0209-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.