Device Recall Normed General Instruments 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Gmbh 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    77262
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2111-2017
  • 사례 시작날짜
    2017-05-11
  • 사례 출판 날짜
    2017-05-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Burr, orthopedic - Product Code HTT
  • 원인
    The devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
  • 조치
    Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated  May 11 2017. Lot Specific notifications were sent to the affected consignee via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to call Technical Services at 1-574-371-3071.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lots: 13065 13569 13571
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Single US consignee CO.
  • 제품 설명
    Normed General Instruments || 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft || The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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