Device Recall BIOLOX

  • Model / Serial
    part number: 650-1162 lot number: 2016030466
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US in the state of Texas
  • Product Description
    DELTA CER FEM HD 32/0MM T1 || Product Usage: || For use in hip arthroplasty
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
  • Product Description
    Ceramic Femoral Head. || Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
  • Manufacturer