Blue Ortho: Device Recall
Recall #Z-0209-2025 · 08/30/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0209-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Blue Ortho
- Status
- Ongoing
- Date Initiated
- 08/30/2024
- Location
- Meylan, N/A, France
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 software units
Reason for Recall
Predict+ is being recalled for lack of pre-market clearance/approval.
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
Distribution Pattern
US Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.