Device Recall Trinity Acetabular System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Corin USA Limited 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
    73205
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1526-2016
  • 사례 시작날짜
    2016-01-29
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • 원인
    Potential for abrasion of the sterile barrier pouches of the new packaging system.
  • 조치
    Corin sent an Urgent Medical Device Recall letter dated February 3, 2016. The letter identified the affected product, problem and actions to be taken. On January 29, 2016, Eight (8) of 11 distributors were spoken to during a Corin National Sales Meeting informing them of the recall. The 3 remaining distributors were notified by phone calls same date. Also, on February 2, 2016 Corin sent a Recall Letter to their Foreign consignee informating them of the recall of the Trinity Acetabular Shell and the actions to be take by the costumers including the return of the Customer Response Form and Contact information as Corin LTD Compliance Director at +44 (0) 1285 649190 Monday thru Friday 8:30am to 5:00pm UK Time

Device

  • 모델명 / 제조번호(시리얼번호)
    Non Occluded TPS Shell 048mm Taper SZ2, Lot Code: 323741
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.
  • 제품 설명
    Trinity Acetabular System || Product Usage - Total Hip Replacement.
  • Manufacturer

Manufacturer