Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0209-2025 · Posted 2024-10-24

Recalling FirmBlue Ortho
Recall StatusOpen, Classified
Product CodeN/A
Date Initiated2024-08-30
Product Quantity136 software units

Reason for Recall

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

Firm Action

Blue Ortho issued a DHCP notice to its active users on 08/30/2024 via email. The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved. There are no actions users need to take. Blue Ortho requested users confirm receipt of the email.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑