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U.S. Department of Health and Human Services

Class 2 Device Recall ComputerAssisted Surgical Device

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  Class 2 Device Recall ComputerAssisted Surgical Device see related information
Date Initiated by Firm July 29, 2016
Create Date November 18, 2017
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-0116-2018
Recall Event ID 77741
510(K)Number K151359  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA BRAIN 3.0.0
Code Information Serial No. BR16017 and BR16018
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin Escapule
574-267-6131
Manufacturer Reason
for Recall		 Non-conforming product label.
FDA Determined
Cause 2		 Error in labeling
Action All affected devices received a corrected label. Correction notification and implementation were performed by field technicians.
Quantity in Commerce 2 devices
Distribution OH and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = MEDTECH S.A.
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