Device Recall Zimmer

  • Modelo / Serial
    Item numbers: 19.32.05; 19.32.06; 19.32.08;  Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Descripción del producto
    Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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

263 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lots 08686600 and 08686800.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product.
  • Manufacturer
  • Modelo / Serial
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
  • Manufacturer
  • Modelo / Serial
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
  • Manufacturer
  • Modelo / Serial
    Lots 08686700 and 08686500.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
  • Manufacturer
  • Modelo / Serial
    All lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution --- USA and countries of Australia and China
  • Descripción del producto
    Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
  • Manufacturer
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