Devices

Device Recall ROIA Anterior Delivery Device

  • Model / Serial
    Lot # 2295101A, 2295101A-R, 2296101A-R
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
  • Product Description
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 || Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
  • Manufacturer
    LDR Spine USA, Inc.
  • 1 Event

Manufacturer

LDR Spine USA, Inc.
  • Manufacturer Address
    LDR Spine USA, Inc., 13785 Research Blvd Ste 200, Austin TX 78750-1895
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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