The recall on Zimmer Biomet’s Rosa Brain 3.0 devices for robot-assisted neurosurgery procedures have been given a Class I designation by the US Food and Drug Administration (FDA). Class I is the most serious type of recall.

Zimmer Biomet issued a warning about the problem in September 2019. The issue revolves around a sequence workflow that can trigger “a discrepancy between initial skin marking on the skull and instrument trajectory,” the Warsaw, Ind.-based company said.

The Rosa device is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. It is composed of a robotic arm and touchscreen mounted on a stand. Different types of instruments may be attached to the end of the robotic arm.

The FDA said the problem causes an incorrect positioning of the robotic arm. The company reported that one patient has been injured but that no deaths were reported in connection with the software problem.

Affected devices were manufactured between Feb. 23, 2016, and Dec. 21, 2018. They were distributed until March 2019. The recall covers 86 units in the U.S.

Zimmer Biomet is using Rosa Brain 3.0 to compete with Stryker, which is speaking at The Robot Report‘s Healthcare Robotics Engineering Forum, in the robot-assisted ortho space. Zimmer Biomet acquired the initial Rosa technology through its roughly $132 million purchase of French robot-assisted surgery firm Medtech in 2016.

In May 2017, Zimmer Biomet issued a voluntary medical device field action for its Rosa Brain, Rosa Spine and Rosa One surgical robotic platforms over movement issues with the systems’ robotic arms.

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The Robot Report is launching the Healthcare Robotics Engineering Forum, which will be on Dec. 9-10 in Santa Clara, Calif. The conference and expo will focus on improving the design, development, and manufacture of next-generation healthcare robots. Learn more about the Healthcare Robotics Engineering Forum, and registration is now open.

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Zimmer Biomet beats Q3 forecast

Despite the recall, Zimmer Biomet earlier in the week reported third-quarter results that beat the consensus forecast on Wall Street. It reported profits of $432 million, or $2.08 per share, on sales of $1.89 billion for the three months ended Sept. 30, 2019, nearly tripling the bottom line and growing sales 3% compared with Q3 2018.

Adjusted to exclude one-time items, earnings per share were $1.77, two pennies ahead of The Street, where analysts were looking EPS of $1.75 on sales of $1.87 billion.

“Our global team delivered strong results this quarter, fueled by a clear focus on our strategic priorities and key new product introductions,” Zimmer Biomet CEO Bryan Hanson said.

“I’m excited by the momentum across the organization and am grateful for the commitment and winning spirit from our team members around the world,” Hanson said.

Zimmer Biomet’s guidance for the full fiscal year remains unchanged: adjusted EPS of $7.75 to $7.90 and a top-line growth outlook of flat to 0.5%.