Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
This recall is currently active, issued October 24, 2024. It was issued by Blue Ortho 22 Chemin Du Vieux Chene Meylan France.
- Recall Initiated
- August 30, 2024
- Posted
- October 24, 2024
- Recall Number
- Z-0209-2025
- Quantity
- 136 software units
- Official Source
- View on FDA website ↗
Reason for Recall
Predict+ is being recalled for lack of pre-market clearance/approval.
Distribution
US Nationwide distribution.
Lot / Code Info
Software version v1.3
Root Cause
No Marketing Application
Action Taken
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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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.