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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 May 27, 2016
Create Date November 17, 2017
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-0105-2018
Recall Event ID 77742
510(K)Number K101791  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Brain 3.0
Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Code Information Serial No. BR16004, BR15002, and BR15003
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		 Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
FDA Determined
Cause 2		 Process control
Action Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.
Quantity in Commerce 3 units
Distribution Worldwide Distribution - US (DC) and Internationally to 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 SAS
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