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Software Error Prompts Zimmer Biomet To Recall Rosa One Robotic Neurosurgery Platform

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  • Zimmer Biomet Holdings Inc (NYSE: ZBH) is facing a Class I recall of its Rosa One Brain platform.

  • Devices ranging from biopsy needles to endoscopes to deep brain stimulation electrodes can be attached to the end of the Rosa One arm and programmed to perform minimally invasive procedures.

  • According to the FDA’s recall notice, an error in the 3.1 version of the system’s software could cause the instruments to be incorrectly placed during stereotactic neurosurgeries.

  • For example, the agency said, coordinates entered into the system to send a tool to a specific location in the brain could be misinterpreted, sending the tool to the wrong area and potentially leading to stroke, serious injury, severe disability, or death.

  • There have been three complaints about this device issue. There have been no deaths or injuries reported about this device issue.

  • The recall spans a total of 119 devices distributed across the U.S., according to the FDA.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: ZBH shares closed up 1.87% at $145.79 on Monday.

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