Device Recall Comprehensive Shoulder System

  • Modèle / numéro de série
    PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide in the states of MN, NJ, CA, TX, ND
  • Description du dispositif
    Humeral Stem 55mm(Size 13) || Product Usage: || Intended for primary and revision total shoulder arthroplasty as well as hemi-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
    PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide in the states of MN, NJ, CA, TX, ND
  • Description du dispositif
    Humeral Stem 83mm(Size 17) || Product Usage: || Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
  • Manufacturer