Device recall
Z-0209-2025: Predict+ is a data-driven, clinical decision support tool that uses machine…
FDA device recall · Class II · Blue Ortho
Key facts
| Recall number (Z-number) | Z-0209-2025 |
|---|---|
| Recall event | 95322 |
| 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 |
| Recalling firm | Blue Ortho |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3008027912 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database