Feb

2018

ROSA Brain 3.0 Cl II

Company:Zimmer Biomet, Inc.
Date of Enforcement Report 2/28/2018
Class lI:

PRODUCT

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Recall Number Z- 0637-2018

REASON
Robot arm being sent to the wrong position-2018

RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16

DISTRIBUTION
Nationwide

___________________________________

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 Brain 3.0 Cl II

Amy Sellers

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