Device Recall RingLoc ArComXL Highly Crosslinked Polyethylene Liners

  • Modèle / numéro de série
    Item XL-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680  Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (nationwide) and Internationally to ARGENTINA
  • Description du dispositif
    RingLoc ArComXL Highly Crosslinked Polyethylene Liners || ArComXL High Wall +3mm Liners Size 23 item XL-108323 || ArComXL MaxRom +3mm Liners Size 23 item XL-108223
  • 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