Events

Ascension MCP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ascension Orthopedics, 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
    25057
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0550-03
  • 사례 시작날짜
    2002-10-31
  • 사례 출판 날짜
    2003-02-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25089
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    unknown device name - Product Code ---
  • 원인
    Literature approved for international distribution only was distributed domestically.
  • 조치
    The firm began to contact all US distributors on October 31, 2002, and all US sales representatives on November 1, 2002, by e-mail to initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.

Device

Ascension MCP
  • 모델명 / 제조번호(시리얼번호)
    Brochure intended for international distribution, Document: LC-04-107-011
  • 의료기기 분류등급
    Orthopedic Devices
  • 유통
    AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, VA, SC, MD, MA, CT, VT, ME, ID, LA, WI, NE
  • 제품 설명
    Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
  • Manufacturer
    Ascension Orthopedics, Inc

Manufacturer

Ascension Orthopedics, Inc
  • 제조사 주소
    Ascension Orthopedics, Inc, 8200 Cameron Road, Ste C-140, Austin TX 78754-3832
  • Source
    USFDA