Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ROSA Brain 3.0.0 Usage: The device is intended for the Recalled by Zimmer Biomet, Inc. Due to Communication errors between ROSANNA BRAIN software, MARIO software...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet, Inc. directly.
Affected Products
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Quantity: 18 (14 US and 4 OUS)
Why Was This Recalled?
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Biomet, Inc.
Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report