Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1191-2019 — 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 robot-assisted control of the Flex Colorectal Drive during visualization of and

U.S. FDA — Device Enforcement · United States · 2019-01-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1191-2019
Date of alert: 2019-01-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medrobotics Corporation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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