Class I Recall of Zimmer Biomet ROSA Brain Robotic Surgery System

Megan Brooks

Disclosures

November 07, 2019

Zimmer Biomet has recalled the ROSA brain 3.0 robotic surgery system due to a software problem that can drive the robotic arm to an incorrect position resulting in risks for the patient, according to a statement posted on the US Food and Drug Administration (FDA) website.

The FDA has identified this as a Class I recall, the most serious kind, because of the potential for serious injuries or death.

Zimmer Biomet has received five complaints related to this issue, including one patient injury. No deaths related to this issue have been reported to date.

The ROSA brain device is a robotic platform that helps neurosurgeons position medical instruments or implants during surgery. The device includes 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 depending on the procedure to be completed.

The recall covers the ROSA brain device v3.0.0.0 (v3.0.0.16 software) and v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software).

The devices were manufactured between February 23, 2016, and December 21, 2018, and distributed between April 8, 2016, and March 19, 2019. A total of 66 devices in the United States have been recalled. A full list of affected product codes is in the FDA's recall notice.

The company sent customers an urgent medical device correction letter with instructions for a workaround for the issue. Customers were also advised of the workflow that would cause the problem to occur.

Zimmer Biomet is providing a label containing the workaround instructions that could be applied directly and they are sending an engineer to each customer site to implement software version 3.1 to correct the issue.

Customers who have questions or concerns regarding this recall, may contact Perry Twyford at 281-389-3236 between 9:00 am and 6:00 pm EST, Monday through Friday. Questions may also be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

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