Events

Model M / DN Intramedullary Humeral Fixation Plates. Catalog No. 00-2254-255-10; Lot # 20855000 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Zimmer Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    393
  • 날짜
    2002-02-15
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The angled proximal drilling of some humerus plates above may be incorrectly oriented, making it impossible for the surgeon to guide the insertion of the screw into the target hole. the manufacturer initiated a correction by letter dated 30 october 2001.
  • 조치
    Verify that you received the letter dated October 30, 2001; operating room questionnaire; prepaid card; addressed envelope; Zimmer distribution history report. Identify and isolate any affected product in your inventory. Contact your local Zimmer representative, who will return the affected product to the Zimmer service department. With the return of the product, you will receive the free replacement and total credit. Fill out the operating room questionnaire, and mail it to Connie Morgan, Zimmer, via prepaid mail, or via fax at (1574) 372-4265. For more information, please contact your local Zimmer representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Model M / DN Intramedullary Humeral Fixation Plates. Catalog No. 00-2254-255-10; Lot # 20855000
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • Source
    ANVSANVISA