Events

Recall of PERSONA THE PERSONALIZED KNEE SYSTEM - ARTICULAR SURFACE INSERTER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZIMMER 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
    64817
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-16
  • 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 is initiating a lot specific recall of persona tibial articular surface inserters due to the potential for deformation of the tip. the instrument may not remain attached to the tibial baseplate during insertion of the articular surface. an investigation found that a group of 360 units did not undergo a heat treatment hardening step resulting in a lack in material strength that may contribute to deformation of the tip over time.

Device

PERSONA THE PERSONALIZED KNEE SYSTEM - ARTICULAR SURFACE INSERTER
  • Model / Serial
    Model Catalog: 42-5299-001-00 (Lot serial: 56574317); Model Catalog: 42-5299-001-00 (Lot serial: 56574291)
  • Product Description
    PERSONA ARTICULAR SURFACE INSERTER
  • Manufacturer
    ZIMMER INC.

Manufacturer

ZIMMER INC.
  • Manufacturer Address
    WARSAW
  • 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