Zimmer Biomet Recalls ROSA One 3.1 Brain Application

Serious injuries or death may result from the use of these devices. This is classified as a Class I recall, the most serious type of recall.

If your email program has trouble displaying this email, view as a webpage. Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software Zimmer Biomet is recalling this product due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures (for example, techniques to direct the tip of a tool using coordinates provided by medical imaging to reach a specific part of the brain). If this error happens, this could cause adverse events such as stroke, serious injury, severe disability, and death.  The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? If you have questions about this recall, contact your Zimmer Biomet representative or customer service by email at Medtech-CHT@zimmerbiomet.com or by phone at (574) 373-5097.

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