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.