Devices

Discovery Elbow System with Humeral Condyle

  • Model / Serial
    LOT 183300
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.
  • Product Description
    Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 || Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.
  • 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