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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 Devicesee related information
Date Initiated by FirmNovember 06, 2014
Create DateNovember 20, 2017
Recall Status1 Terminated 3 on July 13, 2020
Recall NumberZ-0160-2018
Recall Event ID 77626
510(K)NumberK092239 K101791 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductROSA 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/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactKevin W Escapule
574-267-6131
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
ActionAll 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.
Quantity in Commerce31 units
DistributionUS distribution in AR, GA, OH, MI, and TX.
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
510(K)s with Product Code = HAW
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