Device Recall MTX Dental Implant

  • Modelo / Serial
    Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
  • Descripción del producto
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US, Canada, France, Italy, Spain, Germany
  • Descripción del producto
    Tapered Screw-Vent MTX Model TSVTB11
  • Manufacturer
  • Modelo / Serial
    Lot No. 63621027, UDI #(01)00889024019928 (17)220331 (10)63619437.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
  • Descripción del producto
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
  • Manufacturer