Devices

Device Recall Oxford Partial Knee System Left Medial Tibial Trial Tray Size F

  • Modèle / numéro de série
    Item: 32-420822, Lots: ZB160501 ZB160601 ZB160701
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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
  • Description du dispositif
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size F || Product Usage: || Instruments for use with the Oxford Uni Partial Knee System
  • Manufacturer
    Biomet U.K., Ltd.
  • 1 Event

Fabricant

Biomet U.K., Ltd.
  • Adresse du fabricant
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend South Wales United Kingdom
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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