Predict+ is a data-driven — Class II medical device recall Z-0209-2025
Ongoing recall by Blue Ortho, reported 2024-10-30, distributed nationwide. Predict+ is being recalled for lack of pre-market clearance/approval.
| Recall number | Z-0209-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Ortho, Meylan, N/A, France |
| Recall initiated | 2024-08-30 |
| Classified | 2024-10-24 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 136 software |
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
Reason for recall
Predict+ is being recalled for lack of pre-market clearance/approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0209-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.