Device Recall Lineum HF Torque Handle Limit (Lineum)

  • Model / Serial
    538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 || P_roduct Usage: || Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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