Device Recall BIOLOX

  • Modèle / numéro de série
    part number: 650-1162 lot number: 2016030466
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US in the state of Texas
  • Description du dispositif
    DELTA CER FEM HD 32/0MM T1 || Product Usage: || For use in hip arthroplasty
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
  • Description du dispositif
    Ceramic Femoral Head. || Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
  • Manufacturer