Home / Recalls / Blue Ortho / Z-0209-2025

Z-0209-2025 Class II Ongoing

Recalled by Blue Ortho — Meylan, N/A

Recall Details

Product Type: Devices
Report Date: October 30, 2024
Initiation Date: August 30, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 136 software units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

Software version v1.3