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U.S. Department of Health and Human Services

Class 2 Device Recall MEDTECH ROSA Spine 1.0.2

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  Class 2 Device Recall MEDTECH ROSA Spine 1.0.2 see related information
Date Initiated by Firm February 27, 2017
Date Posted March 27, 2017
Recall Status1 Terminated 3 on August 06, 2019
Recall Number Z-1755-2017
Recall Event ID 76820
510(K)Number K151511  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product MEDTECH ROSA Spine 1.0.2
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons 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 lumbar vertebrae with a posterior approach.
Code Information Serial #'s: SP16008
Recalling Firm/
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Service
800-874-7711 Ext. 9225
Manufacturer Reason
for Recall
Unapproved change made by the supplier.
FDA Determined
Cause 2
Component change control
Action Zimmer Biomet sent an Urgent Medical Device Recall Correction letter on February 27, 2017,to all affected customers informing them of the following: Description of the issue: A robot arm file parameter linked to arm calibration was modified by the robot arm supplier without notification to MEDTECH. As a result, once the robot arm is on trajectory, an error leading to a device reboot may decrease the devices applicative accuracy, one of the essential performance requirements, to a level above the specification. This may happen after a shutdown of the device, (voluntary or due to an error), without a return of the robot arm position to a Parking position. In the worst case scenario, this may cause an incorrect positioning of the instruments by the ROSA devices. If this is not detected by the user this could ultimately lead to ineffective treatment, serious injury or even death of the patient. MEDTECH did not record, in normal conditions of use, any customer reports linked to this issue. Required actions by users: Pending the implementation of a permanent correction, MEDTECH is recommending the following actions to all users of the ROSA device: 1- After a shutdown of the device, (voluntary or due to an error), without a return of the robot arm in Parking position, ROSA device must be switched off with the I/O switch button on the device rear panel. 2- Restart the device after 10 seconds, and after full extinction of emergency button light. If the Reset button at the device rear panel is red, restart the ROSA PC by pushing the Reset button. 3- If robot position is NOT ¿ Home ¿, load patient folder and main software interface will appear on the screen. a. Go to the Guidance menu, select trajectories and follow instructions. b. Click on Start button. c. Start recovery procedure and follow all instructions displayed on the screen until robot arm position is Home. d. Close the patient folder e. Click on Exit and follow all ins
Quantity in Commerce 1
Distribution Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
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.