FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Zimmer Biomet Recalls Robotic Surgery System

Nov. 12, 2019

Zimmer Biomet has pulled its ROSA Brain 3.0 robotic surgery system over a software error that caused the device’s robotic arm to position itself incorrectly.

The recall was designated as Class I because the software glitch poses serious risks to patients if the neurosurgical device’s robotic arm moves to an incorrect position.

The company said it received five complaints, but only one involved an injury and it was not fatal.

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