Events

Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments, Instruments Div. 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
    26415
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0921-03
  • 사례 시작날짜
    2003-06-01
  • 사례 출판 날짜
    2003-07-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-11-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27645
  • 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 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 data.
  • 데이터 추가 비고
  • 원인
    Non-sterilized product sold as sterile.
  • 조치
    Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail

Device

Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral ...
  • 모델명 / 제조번호(시리얼번호)
    lot 03030232.
  • 의료기기 분류등급
    Orthopedic Devices
  • 유통
    United States, Canada, Italy, Japan and United Kingdom
  • 제품 설명
    Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
  • Manufacturer
    Stryker Instruments, Instruments Div.

Manufacturer

Stryker Instruments, Instruments Div.
  • 제조사 주소
    Stryker Instruments, Instruments Div., 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA