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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 Devicesee related information
Date Initiated by FirmApril 08, 2016
Create DateNovember 18, 2017
Recall Status1 Terminated 3 on July 13, 2020
Recall NumberZ-0115-2018
Recall Event ID 77743
510(K)NumberK101791 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductROSA 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/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactKevin Escapule
574-267-6131
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
ActionField Service Technicians visited consignee locations to perform system upgrades and have been completed.
Quantity in Commerce64 units
DistributionAL, 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 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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