Devices

Device Recall Artificial ligament fixation device

  • Model / Serial
    Lot Numbers: 047510, 050400, 050420, 089710, 089800, 182820, 192240, 192250, 192280, 219260, 219270, 219280, 228530, 228550, 228580, 228590, 228610, 228620, 295450, 361020, 361020, 392930, 392990, 483490, 483500, 529380, 527780, 529800, 529810, 582890, 582910, 627510, 648470, 648480, 671130, 671150, 671170, 671180, 671190, 671240, 706150, 706160, 782360, 782370, 821710, 821730, 943000, 943010, 943030, 952040, 952070 and 974140.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.
  • Product Description
    Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. || Intended for soft tissue to bone fixation.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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