Events

Recall of Device Recall MEDTECH ROSA Brain 3.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Biomet, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76820
  • Event Risk Class
    Class 2
  • Event Number
    Z-1754-2017
  • Event Initiated Date
    2017-02-27
  • Event Date Posted
    2017-03-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154304
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neurological stereotaxic Instrument - Product Code HAW
  • Reason
    Unapproved change made by the supplier.
  • 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

Device

Device Recall MEDTECH ROSA Brain 3.0
  • Model / Serial
    Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023 and BR16025.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
  • Product Description
    MEDTECH ROSA Brain 3.0 || 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 (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA