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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 December 18, 2013
Create Date November 16, 2017
Recall Status1 Terminated 3 on June 29, 2020
Recall Number Z-0096-2018
Recall Event ID 77598
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 Model Number: ROSA 2.5.8
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W Escapule
574-372-4487
Manufacturer Reason
for Recall		 Possible break in the connector of the Force Sensor.
FDA Determined
Cause 2		 Device Design
Action Customers were informed onsite by Field Service Technicians of the planned correction.
Quantity in Commerce 21 units total
Distribution Nationwide Distribution to OH, MI, and TX
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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