Events

Recall of Device Recall Computer Assisted Surgical Device

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
    77672
  • Event Risk Class
    Class 2
  • Event Number
    Z-0178-2018
  • Event Initiated Date
    2013-02-10
  • 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=157472
  • 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
    Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
  • Action
    Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.

Device

Device Recall Computer Assisted Surgical Device
  • Model / Serial
    Serial No. RO10011, RO10014, RO13023 and RO13027
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AR, OH, MI, and TX
  • Product Description
    ROSA Surgical Device 2.5.8
  • 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