Events

Device Recall Integra Dermal Regeneration TemplateTS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp 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
    50899
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1035-2009
  • 사례 시작날짜
    2009-01-16
  • 사례 출판 날짜
    2009-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77621
  • 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
    Dermal Replacement Device - Product Code MDD
  • 원인
    Potential for open seals in the inner foil pouch of certain products. the outer seal remains intact and therefore the sterility of the inner pouch is maintained.
  • 조치
    Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.

Device

Device Recall Integra Dermal Regeneration TemplateTS
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.
  • 제품 설명
    Integra Dermal Regeneration Template-TS || Catalog number 32021 || Catalog number 82021
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp