Devices

Device Recall NCB Polyaxial Locking Plate System NCB screws

  • Modèle / numéro de série
    Part number 02.03155.026, lot 2649941
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
  • Description du dispositif
    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile || Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Fabricant

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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