FDA Medical devices recall ·
Predict+ is a data-driven, clinical decision support tool that uses… recall
- Recall number
- Z-0209-2025
- Date
- (initiated August 30, 2024)
- Company / brand
- Blue Ortho
22 Chemin Du Vieux Chene, Meylan, N/A, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 136 software units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Predict+ is being recalled for lack of pre-market clearance/approval.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software version v1.3
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0209-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.