Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software version v1.3
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Blue Ortho
- Reason for Recall:
- Predict+ is being recalled for lack of pre-market clearance/approval.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
Software version v1.3
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0209-2025
Related Recalls
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).