Device Recall Zimmer Anatomical Shoulder Handle for Rasp

  • Modèle / numéro de série
    Lot Number(s):  13870129 &  13878179.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
  • Description du dispositif
    Anatomical Shoulder Handle for Rasp || Item: 01.04233.000 || Used during total joint arthroplasty of the shoulder.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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