Class 2 Device Recall Predict

• Date Initiated by Firm: August 30, 2024
• Date Posted: October 24, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0209-2025
• Recall Event ID: 95322
• Product Classification: unknown device name - Product Code N/A
• Product: Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
• Code Information: Software version v1.3
• FEI Number: 3008027912
• Recalling Firm/ Manufacturer: Blue Ortho; 22 Chemin Du Vieux Chene; Meylan France
• For Additional Information Contact: Matthieu Coic; 04-58003525
• Manufacturer Reason for Recall: Predict+ is being recalled for lack of pre-market clearance/approval.
• FDA Determined Cause: No Marketing Application
• 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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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.
• Quantity in Commerce: 136 software units
• Distribution: US Nationwide distribution.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.