ROSA Surgical Device 2.5.8. Cl II

Company:Zimmer Biomet, Inc
Date of Enforcement Report 11/22/2017
Class lI:

PRODUCT

ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
Recall Number Z-0102-2018

REASON
An undetected shift between the information displayed in the navigation software and the actual patient anatomy

RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc.Warsaw, IN on 2/14/2014. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
OH, MI and TX

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