Events

Device Recall Neos Vanadium Excavator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sybron Dental Specialties 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
    50763
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0158-2010
  • 사례 시작날짜
    2008-11-14
  • 사례 출판 날짜
    2009-11-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77094
  • 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
    Excavator, Dental, Operative - Product Code EKC
  • 원인
    The tips of the neos vanadium excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
  • 조치
    Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled "URGENT MEDICAL DEVICE RECALL," informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account. The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address: KerrHawe SA Via Strecce 4 CH-6934 Bioggio Switzerland PLEASE LABEL RETURNED PRODUCT "RECALLED PRODUCT RETURN". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14

Device

Device Recall Neos Vanadium Excavator
  • 모델명 / 제조번호(시리얼번호)
    Batch Numbers: 3105358
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
  • 제품 설명
    Neos Vanadium Excavator Part Number 591/5 SCHE
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • 제조사 주소
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA