Company:Zimmer Biomet, Inc
Date of Enforcement Report 12/6/2017
Class lI:

PRODUCT

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.
Recall Number Z-0177-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc.Warsaw, IN on 10/29/2015. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2

DISTRIBUTION
France and Germany

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