Events

Device Recall DYNASTY(R) BIOFOAM(R) SHELL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wright Medical Technology Inc 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
    60947
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1023-2012
  • 사례 시작날짜
    2012-01-03
  • 사례 출판 날짜
    2012-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106865
  • 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
    Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
  • 원인
    The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
  • 조치
    Wright Medical sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. A Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact Customer Service at 1-800-238-7117 for questions regarding this recall.

Device

Device Recall DYNASTY(R) BIOFOAM(R) SHELL
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 079868628, 1381030, 1388097, 1393856, 1393857, 010970898, 020980982, 050988038, 069850102, 079874285, 099898324, 099914623, 109919440, 109921942, 109925742, 119930202, 119932931, 129966043, 129967123, 0201001768, 0211256650, 0301023179, 0501014643, 0501027674, 0501035748, 0501047117, 0501055979, 0501082871, 0501099070, 0501110611, 0501112343, 0501117006, 0611344248, 0611373194, 0611378062, 0611378106, 0711364808, 0711364846, 0711367610, 0801144284, 0801150056, 0901146269, 1201201703, 1201220323, 06984653810
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
  • 제품 설명
    DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. || The instrument is used as a hip acetabular shell.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • 제조사 주소
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • 제조사 모회사 (2017)
    Wright Medical Group NV
  • Source
    USFDA