Devices

Device Recall Mallory Head 4 Finned Acetabular Shell 50mm

  • Model / Serial
    Catalog Number: 13-104150 Lot Number Identification: 364600
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of VA and TX and the country of Japan.
  • Product Description
    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    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