November 14, 2019

FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System

Editor's Note

The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious.

The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five complaints related to this issue, including one patient injury. No deaths have been reported.

Distribution dates for the system were April 8, 2016, to March 19, 2019.


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