Device 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
Z-0209-2025
Product summary
- Firm
- Blue Ortho
- Event
- Event 95322
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 136 software units
- Official record key
device-enforcement:Z-0209-2025
Official wording
Reason: Predict+ is being recalled for lack of pre-market clearance/approval.
Code information: Software version v1.3
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Predict+ is being recalled for lack of pre-market clearance/approval.