Device Recall Arcos Modular Revision System Torque Limiting THandle

  • Modèle / numéro de série
    419402, 419403, 419404 and 419405.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including the states of CA, NY, FL, VA, UT, IL, MI, KY, OH, MA, PA, SD, MO, TX, NV, Puerto Rico, and the countries of Australia, New Zealand, Canada.
  • Description du dispositif
    ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. || The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.
  • Manufacturer
  • 1 Event

Fabricant

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