Devices

Device Recall Optilock, Locking Screw 3.5mm x 28mm

  • Model / Serial
    Item 37728, Lot 989520; Lot 850910 ; Lot 091250   Lot 429270
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.
  • Product Description
    Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. || Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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