Events

Device Recall 3i 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Implant Innovations, 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
    28092
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0383-04
  • 사례 시작날짜
    2003-12-02
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31187
  • 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
    Drill, Bone, Powered - Product Code DZI
  • 원인
    The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
  • 조치
    The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level. Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter. Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.

Device

Device Recall 3i
  • 모델명 / 제조번호(시리얼번호)
    Lot # 219630
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
  • 제품 설명
    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DC500 LOT 5.0mm Implant Disposable Countersink Pilot Drill STERILE
  • Manufacturer
    Implant Innovations, Inc.

Manufacturer

Implant Innovations, Inc.
  • 제조사 주소
    Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Source
    USFDA