Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled Recalled by Zimmer Biomet, Inc. Due to Potential failure of the optical distance sensor due...
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 Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Quantity: 14 units
Why Was This Recalled?
Potential failure of the optical distance sensor due to cable disconnection.
Where Was This Sold?
This product was distributed to 2 states: MI, OH
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