Events

Recall of A.T.S. 4000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZIMMER BIOMET CANADA 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
    32512
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Zimmer biomet is communicating a newly shortened separation distance of 1.0m between rf communication equipment to mitigate the potential for electromagnetic interference and achieve optimal performance of the tourniquet machines. zimmer is providing an on-device label and updated operator/service manual pages to notify customers of this newly established separation distance to allow for a smaller distance between equipment suitable for smaller or settings.

Device

A.T.S. 4000
  • Model / Serial
    Model Catalog: 60-4000-101-00 (Lot serial: ALL LOTS); Model Catalog: 60-2200-101-00 (Lot serial: ALL LOTS)
  • Product Description
    A.T.S 4000TS Tourniquet System w/ Hoses and LOP Sensor;A.T.S 2200TS Tourniquet System w/Hoses
  • Manufacturer
    ZIMMER BIOMET CANADA INC.

Manufacturer

ZIMMER BIOMET CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • 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
    HC