Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ComputerAssisted Surgical Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ComputerAssisted Surgical Devicesee related information
Date Initiated by FirmDecember 18, 2013
Create DateNovember 16, 2017
Recall Status1 Terminated 3 on June 29, 2020
Recall NumberZ-0096-2018
Recall Event ID 77598
510(K)NumberK092239 K101791 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. 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 Model Number: ROSA 2.5.8
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactKevin W Escapule
574-372-4487
Manufacturer Reason
for Recall		Possible break in the connector of the Force Sensor.
FDA Determined
Cause 2		Device Design
ActionCustomers were informed onsite by Field Service Technicians of the planned correction.
Quantity in Commerce21 units total
DistributionNationwide Distribution to 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
-
-