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

Zimmer Biomet Holdings Inc 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.

Overview Rating:

Speculative

0100