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# Zimmer ROSA Brain System Recall Class 1
- URL: https://www.fdaweb.com/zimmer-rosa-brain-system-recall-class-1/
- Published: 2019-11-07T12:00:00.000Z
- Updated: 2026-09-14T15:52:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145449

FDA says a 9/10 Zimmer Biomet recall of 86 ROSA Brain 3.0 robotic surgery systems is Class 1\. The units were recalled due to a software issue that could drive the system robotic arm to an incorrect position, resulting in patient risk. An FDA [notice](https://www.fda.gov/medical-devices/medical-device-recalls/zimmer-biomet-recalls-rosa-brain-30-robotic-surgery-system-due-software-issue-incorrectly-positions?ref=fdaweb.com) says Zimmer has received five complaints related to the issue, including one patient injury .

The notice says the system is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments may be attached to the end of the robotic arm, FDA says, depending on the procedure to be completed.

Zimmer says it is sending engineers to each customer site to implement new software to correct the issue.