Device Recall Disposable Coring Trephine

  • Modelo / Serial
    648180 and 648200.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Descripción del producto
    8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 1 Event

Fabricante

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

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot 804350, exp. 11/30/2014
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Descripción del producto
    7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • Modelo / Serial
    821010 and 821020.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Descripción del producto
    9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • Modelo / Serial
    92620
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Descripción del producto
    10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • Modelo / Serial
    780470
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Descripción del producto
    8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer