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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 1.0.2see related information
Date Initiated by FirmOctober 29, 2015
Create DateNovember 28, 2017
Recall Status1 Terminated 3 on June 16, 2020
Recall NumberZ-0177-2018
Recall Event ID 78443
510(K)NumberK151511 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductRosa 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 ContactKevin 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
ActionZimmer 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 Commerce2
DistributionWorldwide Distribution including France and Germany
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 = OLO
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