Medrobotics Corporation recalls Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an…

Recall date

January 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1192-2019

FDA classification

Class II

Brand / firm

Medrobotics Corporation

Sold / distributed

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.

Why it was recalled

The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.