Tibial Alignment Guide

  • Modèle / numéro de série
    Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
  • Description du dispositif
    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • 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

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  • Modèle / numéro de série
    Model: 20-8011-013-00, Affected: 120265, 120793, 120794, 130135, 130539
  • Manufacturer
  • Modèle / numéro de série
    Model: 20-8011-013-00, Affected: 120265, 120793, 120794, 130135, 130539
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Medical instruments for use in humans - bone surgery
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
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  • Manufacturer
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