Dec

2017

ROSA Surgical Device 2.5.8. Cl II

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

PRODUCT

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.
Recall Number Z-0184-2018

REASON
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.

RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc.Warsaw, IN on 9/5/2014. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
29 (8 US and 21 OUS)

DISTRIBUTION
Nationwide Distribution to AK, OH, TX, GA, and MI

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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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