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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA ComputerAssisted Surgical Device

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  Class 2 Device Recall ROSA ComputerAssisted Surgical Device see related information
Date Initiated by Firm November 06, 2014
Create Date November 20, 2017
Recall Status1 Terminated 3 on July 13, 2020
Recall Number Z-0160-2018
Recall Event ID 77626
510(K)Number K101791  K092239  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Code Information Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037. 
Recalling Firm/
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W Escapule
Manufacturer Reason
for Recall
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
FDA Determined
Cause 2
Device Design
Action All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.
Quantity in Commerce 31 units
Distribution US distribution in AR, GA, OH, MI, and TX.
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