Events

Device Recall SmartSeal Wedge Femoral Pressuriser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Depuy Orthopaedics, 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
    38464
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0176-2008
  • 사례 시작날짜
    2007-07-13
  • 사례 출판 날짜
    2007-11-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53813
  • 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
    Femoral Pressuriser - Product Code KWS
  • 원인
    Package integrity: the outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.
  • 조치
    Sales Force Managers were notified of this recall by an Urgent Information Recall Notice Letter, via email, on 7/13/07 and 7/23/07, to visit their Consignees. Letters for the Hospitals (Dear Materials Manager) and Dear Doctors Letters were provided as background by the Sales Force Managers during their visits. If any product remained in inventory, it should be quarantined immediately, and returned to DePuy. Hospitals should be notified immediately not to use the affected device. Replacement stocks will have a check mark on the bottom right front of package to indicate it has passed inspection.

Device

Device Recall SmartSeal Wedge Femoral Pressuriser
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- including States of Arkansas, California, Colorado, Florida, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, New Mexico, North Carolina, Pennsylvania, South Dakota, Texas, Utah and Washington.
  • 제품 설명
    SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • 제조사 주소
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA