Events

Device Recall GEM 2753 Microvascular Anastomotic Coupler 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synovis Micro Companies Alliance 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
    48974
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2138-2008
  • 사례 시작날짜
    2008-05-14
  • 사례 출판 날짜
    2008-08-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72437
  • 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
    Microvascular Anastomotic Device - Product Code MVR
  • 원인
    Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
  • 조치
    Urgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees.

Device

Device Recall GEM 2753 Microvascular Anastomotic Coupler
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1808, 1894, 1907, 1923, 1953, 1954, 7139, 7211, 7354, 8998, 8999, 11591, 12364, 15244, 15280, 15281, 18824, 18912, 19294, 19413, 19954, 20263, 20689, 21345, 21515, 21560, 21977, 22556, and 23047
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain.
  • 제품 설명
    GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized || This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
  • Manufacturer
    Synovis Micro Companies Alliance Inc

Manufacturer

Synovis Micro Companies Alliance Inc
  • 제조사 주소
    Synovis Micro Companies Alliance Inc, 439 Industrial Ln, Birmingham AL 35211-4464
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA