Raynham, MA, United States
Medrobotics Corporation recalls
1 recall recorded since 2018, most recently on 25 January 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 January 2019
- Terminated
- 11 December 2020
- Reason
- The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1191-2019, Z-1192-2019
- 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
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.