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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 September 05, 2014
Create Date November 28, 2017
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-0184-2018
Recall Event ID 78362
510(K)Number K101791  K092239  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Surgical Device 2.5.8
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Code Information Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035 
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		 The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
FDA Determined
Cause 2		 Software design
Action This is a retrospective report of a correction initiated on 05-Sept-2014. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. There were 8 affected devices at customer sites in the US. Field Service Technicians were deployed to the consignee locations to perform the system upgrade.
Quantity in Commerce 29 (8 US and 21 OUS)
Distribution Nationwide Distribution to AK, OH, TX, GA, and MI
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.
510(K)s with Product Code = HAW and Original Applicant = MEDTECH SAS
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