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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA 3.0 (Brain application)

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  Class 2 Device Recall ROSA 3.0 (Brain application) see related information
Date Initiated by Firm May 01, 2017
Create Date February 16, 2018
Recall Status1 Terminated 3 on July 13, 2020
Recall Number Z-0638-2018
Recall Event ID 78944
510(K)Number K172444  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device.

Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Code Information BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016,  BR16023, and BR16025.
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall		 Robot arm being sent to the wrong position
FDA Determined
Cause 2		 Software design
Action Urgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.
Quantity in Commerce 16
Distribution Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
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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