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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA Spine 1.0.2

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  Class 2 Device Recall ROSA Spine 1.0.2 see related information
Date Initiated by Firm October 29, 2015
Create Date November 28, 2017
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-0177-2018
Recall Event ID 78443
510(K)Number K151511  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
Code Information Serial #'s; SP14003 and SP14005 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W. Escapule
574-267-6131
Manufacturer Reason
for Recall		 A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
FDA Determined
Cause 2		 Software design
Action Zimmer Biomet issued a retrospective report of a correction taken on 29-Oct-2015. The software issue described was corrected in the new software version 1.0.2.16. There were 2 copies of the affected software in distribution. Field Service Technicians were deployed to the consignee locations to perform the system upgrade. 100% of affected devices were updated with the software solution. No further action is required.
Quantity in Commerce 2
Distribution Worldwide Distribution including France and Germany
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 = OLO and Original Applicant = MEDTECH S.A.
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