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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 June 04, 2014
Create Date November 21, 2017
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-0161-2018
Recall Event ID 77750
510(K)Number K101791  K092239  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Surgical Device 2.5.8

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 No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020. 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin Escaule
574-267-6131
Manufacturer Reason
for Recall		 Software corrections reactivating the cooperative endoscopy mode.
FDA Determined
Cause 2		 Software Design Change
Action The firm, Zimmer Biomet Inc., sent Field Service Technicians to consignee locations to perform system upgrade. All US units have been corrected. If you any question, please contact Post Market Surveillance and Regulatory Compliance Director at 574-372-4487 or email to: kevin.escapule@zimmberbiomet.com.
Quantity in Commerce 29 devices(8 US and 21 OUS)
Distribution Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
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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