Recall
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…
Medrobotics Corporation · 25 Jan 2019
- Status
- Recall terminated
- Why, in the FDA's words
- “The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.”
- Recall began
- 25 Jan 2019
- Company
- Medrobotics Corporation
- Device type
- Product code (FDF)
- Concerns
- K162330
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.