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U.S. Department of Health and Human Services

Class 1 Device Recall ROSA One 3.1 Brain application

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  Class 1 Device Recall ROSA One 3.1 Brain application see related information
Date Initiated by Firm September 22, 2021
Create Date October 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-0118-2022
Recall Event ID 88746
510(K)Number K200511  K182417  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA One 3.1 Brain application

The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Code Information Serial Numbers:  US: BS16904 BS16905 BS16906 BS16909 BS16910 BS16911 BS16912 BS16913 BS16914 BS16915 BS16916 BS16917 BS16918 BS16921 BS16923 BS16925 BS17930 BS17934 BS17935 BS17936 BS17937 BS18900 BS18901 BS18924 BS18931 BS18938 BS18939 BS18940 BS18942 BS18943 BS18945 BS18946 BS18947 BS18948 BS18949 BS18950 BS18951 BS18952 BS18953 BS18954 BS18955 BS18956 BS18957 BS18958 BS18959 BS18960 BS18961 BS18962 BS18963 BS18964 BS18965 BS18966 BS18967 BS18968 BS18969 BS18970 BS18971 BS18972 BS18973 BS18974 BS18975 BS18976 BS18977 BS18979 BS18980 BS18981 BS18982 BS18983 BS18984 BS18985 BS18986 BS18987 BS18988 BS18989 BS18990 BS18991 BS18992 BS18993 BS18994 BS18995 BS18996 BS18997 BS18998 BS18999 BS19037 BS19038 BS19039 BS19040 BS19041 BS19043 BS19047 BS19049 BS19050 BS19052 BS19053 BS19054 BS19057 BS19058 BS19059 BS19060 BS19061 BS19065 BS20066 BS20067 BS20072 BS20073 BS20079 BS20080 BS20086 BS20092 BS20100 BS20103 BS20107 BS21112 BS21115 BS21121 BS21129 BS21137 BS21138  OUS:  BS15902 BS15903 BS16007 BS16919 BS16928 BS16929 BS17008 BS17010 BS17013 BS17021 BS17022 BS17023 BS18024 BS18026 BS18027 BS18028 BS18030 BS18031 BS19032 BS19033 BS19034 BS19035 BS19036 BS19042 BS19051 BS19056 BS19062 BS19064 BS20068 BS20069 BS20070 BS20071 BS20074 BS20075 BS20076 BS20077 BS20078 BS20082 BS20084 BS20085 BS20090 BS20095 BS20098 BS20099 BS20102 BS20105 BS20106 BS21108 BS21109 BS21114 BS21124 BS21128 BS21132 BS21133 BS21134 
Recalling Firm/
Manufacturer		 MEDTECH SAS
900 Rue Du Mas De Verchant
Montpellier France
For Additional Information Contact 411 Technical Services
574-3713071
Manufacturer Reason
for Recall		 The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
FDA Determined
Cause 2		 Software design
Action On September 22, 2021, the firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE CORRECTION" letters to affected consignees. Customers were informed of steps that may result in the issue and that should be avoided: After the registration of the patient during the ROSA One 3.1 Brain application procedure, the issue may occur when the device shuts down either manually or unexpectedly. After reboot, if the trajectory is interrupted by deactivating the pedal, the device gives the user an option to Return to HOME , Clear the robotic arm , or Continue . If the user chooses to Clear the robotic arm , the device prompts the user to perform an empty device calibration. If the user performs this step and presses start, the issue will occur, which results in the device driving to an incorrect trajectory. Pending the implementation of a corrective action, Medtech S.A - Zimmer Biomet - advises that the actions detailed below to be taken without delay by all users of the ROSA One 3.1 Brain application device. Required actions by users to prevent incorrect instrument configuration (Workaround): If a shutdown occurs during guidance mode, any empty calibration window that would subsequently appear during the session should be closed by pressing UNDO. Customers were provided with a laminated warning label to attach to the robot. A Zimmer Biomet engineer will visit each customer site to implement a new software version to correct the issue once it is available. It is estimated that the updates will begin approximately in February 2022 and be completed by May 2022. If you have further questions or concerns, please contact your Zimmer Biomet representative or call the Product Surveillance Manager at stephanie.leppo@zimmerbiomet.com.
Quantity in Commerce 119 (US); 55 (OUS)
Distribution US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = MEDTECH S.A.
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