FDAFDA · Food and drugs·Recall number Z-0209-2025
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Published October 30, 2024 · Recall initiated: August 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Predict+ is being recalled for lack of pre-market clearance/approval.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Blue Ortho
- Distributor
- US Nationwide distribution.
- Lot
- Software version v1.3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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