Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder

  • Modelo / Serial
    Model LPCCC2 Lot# 2010101036 and 2010101037.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType;=RCL
  • Descripción del producto
    LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i || Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Empresa matriz del fabricante (2017)
  • 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