FDA Device recall Z-0209-2025
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes…
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes… by Blue Ortho, citing predict+ is being recalled for lack of pre-market clearance/approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0209-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-30 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Blue Ortho |
| Distribution | US |
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
Predict+ is being recalled for lack of pre-market clearance/approval.
Identifiers
| code_info | Software version v1.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0209-2025%22
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