Device recall
Z-2135-2024: CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended…
FDA device recall · Class II · Blue Belt Technologies, Inc
Key facts
| Recall number (Z-number) | Z-2135-2024 |
|---|---|
| Recall event | 94635 |
| Product | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2)… |
| Product code | OLO |
| Recalling firm | Blue Belt Technologies, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K240139 |
| 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