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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA(TM) Robotized Stereotactic Assistant

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 Class 2 Device Recall ROSA(TM) Robotized Stereotactic Assistantsee related information
Date Initiated by FirmMay 08, 2018
Create DateJune 07, 2018
Recall Status1 Terminated 3 on August 19, 2020
Recall NumberZ-2108-2018
Recall Event ID 80061
510(K)NumberK101791 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductROSA(TM) Robotized Stereotactic Assistant, Version 2.5 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 Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069
Recalling Firm/
Manufacturer		 MEDTECH SAS
Parc Euromedecine Batiment 8
1006 rue de la Croix Verte
Montpellier France
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Replacement of units lacking an updated device approval.
FDA Determined
Cause 2		No Marketing Application
ActionMedtech would like to inform you of the planned removal of all ROSA 2.5 devices from the US market by 31st October 2018. The ROSA 2.5 design has been superseded by a newer generation product, ROSA Brain 3.0, and a decision has been made by Zimmer Biomet to exchange all ROSA 2.5 devices in the US market with ROSA Brain 3.0 devices. This decision has been taken in response to a regulatory clearance compliance issue, and there is no safety concern associated with this action. No specific action is required and the ROSA 2.5 can continue to be used at this time. A Medtech representative will be in contact to schedule the exchange of the RO 15 061 device with a ROSA Brain 3.0 device. For further questions, please call (574) 371-3071.
Quantity in Commerce29 units
DistributionUS Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HAW
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