Events

Recall of MALLORY/HEAD FEMORAL STEMS

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

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
    85859
  • Event Risk Class
    II
  • Event Initiated Date
    2001-02-05
  • 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
    A hip stem was rejected for surface irregularity during manufacturing. investigation revealed a streak of pure cobalt in 1 bar of crco alloy which could effect strength of the device.

Device

MALLORY/HEAD FEMORAL STEMS
  • Model / Serial
    Model Catalog: 105607 (Lot serial: 264510 113800 013510 549190); Model Catalog: 105607 (Lot serial: 523810)
  • Manufacturer
    BIOMET ORTHOPEDICS

Manufacturer

BIOMET ORTHOPEDICS
  • 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