Devices

Device Recall Oxford Unicompartmental Knee Phase 3 Tibial Impactor

  • Modelo / Serial
    Item: 32-420932, Lots: ZB160801, ZB160802, ZB160803
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
  • Descripción del producto
    Oxford Unicompartmental Knee Phase 3 Tibial Impactor || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
  • Manufacturer
    Biomet U.K., Ltd.
  • 1 Event

Fabricante

Biomet U.K., Ltd.
  • Dirección del fabricante
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend South Wales United Kingdom
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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