Events

Recall of Device Recall ROSA 1.0.2 (Spine application)

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
    78944
  • Event Risk Class
    Class 2
  • Event Number
    Z-0639-2018
  • Event Initiated Date
    2017-05-01
  • 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=160940
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    Robot arm being sent to the wrong position.
  • Action
    Urgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.

Device

Device Recall ROSA 1.0.2 (Spine application)
  • Model / Serial
    SP16008
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
  • Product Description
    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. || Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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