Home / Recalls / Medical Devices
Medrobotics Corporation recalls Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is
Recalled April 24, 2019 · FDA recall Z-1192-2019 · Medrobotics
Hazard
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. · FDA Class II
Units
24
Sold at
Worldwide Distribution - US Nationwide in the states of CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA. Foreign distribution to Australia and Italy.
Description
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Product
Obturator (shortcone), Part number 26114 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 surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Manufacturer(s)
Medrobotics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →