Device recall
Z-0041-2024: Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software…
FDA device recall · Class II · Blue Belt Technologies, Inc
Key facts
| Recall number (Z-number) | Z-0041-2024 |
|---|---|
| Recall event | 93046 |
| Product | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 |
| Product code | OLO |
| Recalling firm | Blue Belt Technologies, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K231963 |
| FEI number | 3016090213 |
At a glance
- 1–9 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