Device Recall Instinct Java System

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
  • Product Description
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . || Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • 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