Events

Device Recall Ascension PyroCarbon PIP Total Joint Trials 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
    55191
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1524-2010
  • 사례 시작날짜
    2009-06-17
  • 사례 출판 날짜
    2010-05-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90269
  • 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
    Finger semi-constrained pyrolytic carbon uncemented prosthesis - Product Code NEG
  • 원인
    Trial product was larger than actual implant. trial product was re-designed to more closely match the implant.
  • 조치
    Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement. For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549.

Device

Device Recall Ascension PyroCarbon PIP Total Joint Trials
  • 모델명 / 제조번호(시리얼번호)
    All lot codes.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.
  • 제품 설명
    Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. || Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
  • Manufacturer
    Ascension Orthopedics, Inc

Manufacturer

Ascension Orthopedics, Inc