Device Recall Zimmer Hgp ii acetabular cup bone Screw

  • Model / Serial
    LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Product Description
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 || Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 || Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 || Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 || Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 || Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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