Events

InterGro PLUS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Interpore Cross International 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
    45469
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0618-2008
  • 사례 시작날짜
    2007-10-15
  • 사례 출판 날짜
    2008-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-09-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65546
  • 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
    Bone Filler (Calcium) - Product Code MQV
  • 원인
    Unapproved testing:interpore cross international was recently informed that one of its human tissue suppliers, lifelink tissue bank ("lifelink"), utilized unapproved diagnostic testing (hbsag & hbc) on certain lots of distributed donor tissue instead of the fda approved screening test. as a result, interpore cross international has initiated a recall on specific lots of products containing human.
  • 조치
    The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.

Device

InterGro PLUS
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 600107, 600015, 279540, 6000098, 255137, 600550, 600232, 600199, 600180, 279579, 600125, 600126, 600201, 600339, 217530, 783490, 600365, 728840, 608430, 608440, 219980, 882050, 203995, 079160, 788840, 687010, 135970, 247877, 600113, 827220 & 247906
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Interpore Cross International, a Biomet company (lnterGro DBM products contain human tissue (allograft bone) and are intended for transplantation)
  • Manufacturer
    Interpore Cross International Inc

Manufacturer

Interpore Cross International Inc
  • 제조사 주소
    Interpore Cross International Inc, 181 Technology Dr, Irvine CA 92618-2402
  • Source
    USFDA