Devices

Device Recall Biomet Vanguard Instruments LockOn Femoral Impactor

  • 모델명 / 제조번호(시리얼번호)
    Lots 122890, 296900, 424590, 433560, 433570, 433580, 433590, 433600, 646610 and 943990.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.
  • 제품 설명
    Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. || Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

제조사

Biomet, Inc.
  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “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