Device Recall Apollo" Knee System

  • Modelo / Serial
    Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 681604009 681604011 681604013 681604016 681604019 681604022 681605009 681605019
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
  • Descripción del producto
    Apollo" Knee System: || PS TIB INS SZ0/16MM APOLL || PS TIB INS SZ0/19MM APOLL || PS TIB INS SZ0/22MM APOLL || PS TIB INS SZ1/16MM APOLL || PS TIB INS SZ2/16M APOLLO || PS TIB INS SZ2/22MM APOLL || PS TIB INS SZ3/16MM APOLL || PS TIB INS SZ3/19MM APOLL || PS TIB INS SZ4/9MM APOLLO || PS TIB INS SZ4/11MM APOLL || PS TIB INS SZ4/13MM APOLL || PS TIB INS SZ4/16MM APOLL || PS TIB INS SZ4/19MM APOLL || PS TIB INS SZ4/22MM APOLL || PS TIB INS SZ5/9MM APOLLO || PS TIB INS SZ5/19MM APOLL
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Item Number 680001000
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
  • Descripción del producto
    Apollo" Knee System: || APOLLO PATELLA SZ0 28MM R
  • Manufacturer