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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 20, 2016
Create Date November 21, 2017
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-0167-2018
Recall Event ID 78367
510(K)Number K151359  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Brain 3.0.0

Usage:
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Code Information Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and  BR16021 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Mr. Kevin W. Escapule
574-267-6131
Manufacturer Reason
for Recall		 Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
FDA Determined
Cause 2		 Software design
Action This is a retrospective report of a correction initiated on 20-Jul-2016. Customers were informed onsite by field Service Technicians of the planned correction. The software issue described was corrected in the new software version ROSA Brain 3.0.0.20. Field Service Technicians were deployed to the customers locations to perform the system upgrade. .
Quantity in Commerce 18 (14 US and 4 OUS)
Distribution Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
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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