Devices

Device Recall Optilock, Locking Screw 3.5mm x 28mm

  • 모델명 / 제조번호(시리얼번호)
    Item 37728, Lot 989520; Lot 850910 ; Lot 091250   Lot 429270
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.
  • 제품 설명
    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

제조사

Biomet, Inc.
  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “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