Device Recall Zyston Transform TLIF System

  • Model / Serial
    Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
  • Product Description
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet Spine, Inc, 310 Interlocken Pkwy, Suite 120, Broomfield CO 80021-3479
  • 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: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
  • Product Description
    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
  • Manufacturer