Biomet Compehensive Reverse Shoulder

  • Model / Serial
    Lot numbers: 216080, 216090, 216100, 551630, 877130, 8877160, 877180 and 877200.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
  • Product Description
    Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, REF 115350, Biomet Orthopedics, Warsaw, IN || Intended for total shoulder replacement in a reverse configuration.
  • Manufacturer
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
  • Product Description
    Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN || Intended for total shoulder replacement in a reverse configuration.
  • Manufacturer