Device Recall Phoenix Cannulated Recon Screw 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 EBI, L.P. 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
    51725
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2115-2009
  • 사례 시작날짜
    2009-03-27
  • 사례 출판 날짜
    2009-09-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-09-23
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • 원인
    Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
  • 조치
    Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 14-406110; Lot number 517350
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA and Spain.
  • 제품 설명
    Phoenix Cannulated Recon Screw; || Ti-Cann PARTL THD Recon Screw || Trauma Fixation Systems; || Rx only || Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 || Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
  • Manufacturer

Manufacturer

  • 제조사 주소
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA