Device recall
Z-1191-2019: Obturator (long cone), Part number 25162 Product Usage: The obturator is a…
FDA device recall · Class II · Medrobotics Corporation
Key facts
| Recall number (Z-number) | Z-1191-2019 |
|---|---|
| Recall event | 82403 |
| Product | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and… |
| Product code | FDF |
| Recalling firm | Medrobotics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2020 |
| 510(k) numbers | K162330 |
| FEI number | 3009276788 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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