Zimmer Biomet Recalls Rosa One 3.1 Brain Application Due to Software Error

The FDA has deemed Zimmer Biomet’s Sept. 22 recall of its Rosa One 3.1 Brain Application used in neurosurgical procedures to be a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is a software error that could lead to incorrect placement of instruments during stereotactic surgery, a technique for precisely directing the tip of a delicate instrument. If the problem occurs, it could cause adverse events, such as stroke, serious injury, severe disability and death, according to the FDA.  

The 119 affected products were distributed from Dec. 1, 2019, to Aug. 31. There have been three complaints, but no deaths or injuries reported due to the problem, the agency said.