Device recall
Z-0299-2023: regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience…
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-0299-2023 |
|---|---|
| Recall event | 91069 |
| Product | regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit |
| Product code | OJG |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2026 |
| FEI number | 3014527682 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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