Events

Recall of IASSIST KNEE SYSTEM - VALIDATION TOOL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZIMMER CAS.

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
    34748
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-27
  • 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
    An increase of complaints was observed regarding bent or broken drive pins of the validation tool manufactured with drawing revision m to p.

Device

IASSIST KNEE SYSTEM - VALIDATION TOOL
  • Model / Serial
    Model Catalog: 20-8011-021-00 (Lot serial: 140407); Model Catalog: 20-8011-021-00 (Lot serial: 141035); Model Catalog: 20-8011-021-00 (Lot serial: 140147); Model Catalog: 20-8011-021-00 (Lot serial: 150120)
  • Product Description
    IASSIST KNEE SYSTEM - VALIDATION TOOL
  • Manufacturer
    ZIMMER CAS

Manufacturer

ZIMMER CAS
  • Manufacturer Address
    MONTREAL
  • 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