Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device Recalled by Zimmer Biomet, Inc. Due to A design change was initiated to update ROSA...
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 Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
Quantity: 2
Why Was This Recalled?
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Where Was This Sold?
Worldwide Distribution including France and Germany
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