Device Recall CollaGuide Collagen Dental Membrane 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kensey Nash 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
    61819
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1621-2012
  • 사례 시작날짜
    2012-02-28
  • 사례 출판 날짜
    2012-05-17
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-04-11
  • 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
    Barrier, animal source, intraoral - Product Code NPL
  • 원인
    Recall has been initiated due to concerns regarding the sterility of the product. the firm initiated the recall because of use of inadequately sterilized product might result in patient infection,.
  • 조치
    Reimser, Inc. sent an "URGENT PRODUCT RECALL-COLLAGUIDE COLLAGEN DENTAL MEMBRANE" letter dated March 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to cease use, secure and quarantine affect product. Additionally, a Recall Acknowledgement Form was attached for customers to complete and return to the firm via fax to 1-800-505-4982. Contact the firm at 484-713-2197 for questions regarding this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    15mm X 20mm Part Number 20650-01 Lot # 88519 Expiration date 03/31/12  Lot # 92008 Expiration date 09/30/12 Lot # 92067 Expiration date 09/30/12 Lot # 92338 Expiration date 10/31/12 Lot # 94764 Expiration date 03/31/13 Lot # 95275 Expiration date 05/31/13 Lot # 95910 Expiration date 05/31/13 Lot # 97039 Expiration date 08/31/13 Lot # 98318 Expiration date 11/30/13 Lot # 98343 Expiration date 12/31/13 Lot # 84504 Expired Lot # 85270 Expired Lot # 88165 Expired
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. || Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only || 15mm X 20mm || Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. || CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341
  • 제조사 모회사 (2017)
  • Source
    USFDA