Device Recall Tapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform

  • Modèle / numéro de série
    Catalog Number TSVWB11, Lot 62470008.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
  • Description du dispositif
    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. || Class II, 510(k) K13227.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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