Events

AdVance Male Sling System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 American Medical Systems, 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
    56846
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0808-2011
  • 사례 시작날짜
    2010-09-07
  • 사례 출판 날짜
    2010-12-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94623
  • 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
    Polymeric Surgical Mesh - Product Code FTL
  • 원인
    American medical systems (ams) is recalling all lots of the advance male sling system with an expiration date between july 2012 and august 2013. internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture.
  • 조치
    Consignees were sent an AMS "Urgent Product Recall" letter dated September 7, 2010. The letter described the problem and the product involved. They requested consignees to return any existing stock product and to return the Product Recall Acknowledgement form enclosed. Customers may request a credit or a full refund or also, arrange for replenishment of AdVance product. Questions regarding the recall should be directed towards AMS Customer Service at 1-800-328-3881.

Device

AdVance Male Sling System
  • 모델명 / 제조번호(시리얼번호)
    The affected Lot Serial Number Range is 615445001 - 669783001 (The Lot Serial Number is comprised of nine digits. The first 6 digists represent the parent lot number, followed by the last 3 digits which represents the serial number). All lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- All states in the Continental USA including DC and Puerto Rico and countries of ARGENTINA, AUSTRIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, GERMANY, ESTONIA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, CROATIA, IRELAND, ISRAEL, INDIA, ITALY, REPUBLIC OF KOREA, LEBANON, MOROCCO, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, RUSSIAN FEDERATION SAUDI ARABIA, SWEDEN SINGAPORE, SLOVENIA, THAILAND, TURKEY, TAIWAN, VENEZUELA, and SOUTH AFRICA.
  • 제품 설명
    Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. || Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
  • Manufacturer
    American Medical Systems, Inc.

Manufacturer

American Medical Systems, Inc.
  • 제조사 주소
    American Medical Systems, Inc., 10700 Bren Road West, Minnetonka MN 55343-9679
  • Source
    USFDA