Device Recall Locator Restorative Abutment

  • Modelo / Serial
    Lot 877423
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.
  • Descripción del producto
    LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. || BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. || For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.
  • 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