Nov

2017

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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ROSA Surgical Device 2.5.8. Cl II

Amy Sellers

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