Device Recall Coonrad/Morrey

  • 모델명 / 제조번호(시리얼번호)
    Catalog 32-8105-029-00-29; Lot 61722176
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
  • 제품 설명
    Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 || Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 제조사 모회사 (2017)
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 63694912
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in China and Taiwan.
  • 제품 설명
    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot 60039452.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
  • 제품 설명
    Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 60039453, 60039454, 60040852 and 60041552.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
  • 제품 설명
    Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, right, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-02.
  • Manufacturer