Events

Device Recall Abutment Retrieval Instrument 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nobel Biocare Usa Llc 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
    71552
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2074-2015
  • 사례 시작날짜
    2015-06-22
  • 사례 출판 날짜
    2015-07-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138182
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • 원인
    One dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
  • 조치
    A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare Representative.

Device

Device Recall Abutment Retrieval Instrument
  • 모델명 / 제조번호(시리얼번호)
    Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
  • 제품 설명
    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.
  • Manufacturer
    Nobel Biocare Usa Llc

Manufacturer

Nobel Biocare Usa Llc
  • 제조사 주소
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA