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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 April 08, 2016
Create Date November 18, 2017
Recall Status1 Terminated 3 on July 13, 2020
Recall Number Z-0115-2018
Recall Event ID 77743
510(K)Number K101791  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Surgical Device 2.5.8
Code Information Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062 
Recalling Firm/
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin Escapule
Manufacturer Reason
for Recall
Potential for software to change the final tool orientation for the command position without command.
FDA Determined
Cause 2
Software design
Action Field Service Technicians visited consignee locations to perform system upgrades and have been completed.
Quantity in Commerce 64 units
Distribution AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
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 SAS