| Class 2 Device Recall ComputerAssisted Surgical Device |  |
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
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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
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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 Stubli 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 |
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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.
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510(K) Database | 510(K)s with Product Code = HAW
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