Events

DuraGen XS" Dural Regeneration Matrix 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
    56912
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0452-2011
  • 사례 출판 날짜
    2010-11-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94910
  • 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
    Methyl methacrylate for cranioplasty - Product Code GXQ
  • 원인
    Test results no longer support a 3 year shelf life.
  • 조치
    Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers. Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3. Customers were instructed to fill out and return the enclosed "Recall Acknowledgement and Return Form" indicating whether or not they possessed any of the affected product. For any questions related to this recall call 1-800-654-2873 and selection option 1.

Device

DuraGen XS" Dural Regeneration Matrix
  • 모델명 / 제조번호(시리얼번호)
    Catalog number DXM1045, Lot number 1084359, 1091578, 1093431, 1094405, 1095442, 1095784, 1101583, 1101989.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including AK, AL, AZ, CA, CO, DC, DE, FL, GA, HI, IL, IN, LA, MA, MD, ME, MN, MO, MT, NC, ND, NH, NJ, NM, NY, OK, PA, TN, TX, UT, VA, VT, WA, WI, AND WV.
  • 제품 설명
    DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. || Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA || DuraGen XS is indicated as a dural substitute for repair of dura matter.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.