Device Recall Biomet CC IBeam Tibial Plate 75mm

  • Modèle / numéro de série
    REF 141232, LOT J100927055
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands
  • Description du dispositif
    Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    REF 141224, LOT J100921070
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands
  • Description du dispositif
    Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
  • Manufacturer