Devices

Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE

  • Model / Serial
    Part Number 906764, Lots 748580, 748730 and 932650.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: IN and KY; and countries of: Canada and The Netherlands.
  • Product Description
    REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILE || After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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