Device Recall Oxford Fixed Bearing Partial Knee Replacement

  • Modelo / Serial
    M619750 ; M375480; M886380, M956060 , M444700
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Descripción del producto
    REF 154208 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size B4 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

28 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    M619730 , M480920, M656920, M938460, M444630
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Descripción del producto
    REF 154200 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A3 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • Modelo / Serial
    M619740, M492940, M444640, M656930, M938470
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Descripción del producto
    REF 154201 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A4 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • Modelo / Serial
    M879630 , M584360, M492950, M444650, M656940, M938480
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Descripción del producto
    REF 154202 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A5 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • Modelo / Serial
    M879640, M375460, M444660, M886350, M938490
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Descripción del producto
    REF 154203 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A6 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • Modelo / Serial
    M375470, M444680 , M886360, M938500
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • Descripción del producto
    REF 154204 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A7 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
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