Events

Device Recall Replace Select Tapered TiU NP 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
    70821
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1419-2015
  • 사례 시작날짜
    2015-03-09
  • 사례 출판 날짜
    2015-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-12-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135207
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • 원인
    A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
  • 조치
    Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a replacement product. Customers were also instructed to complete the attached Acknowledgement form and fax it to 714-282-5073 or email it to aeinfo@nobelbiocare.com. Customers with questions were instructed to contact their customer service department. For questions regarding this recall call 714-282-4800.

Device

Device Recall Replace Select Tapered TiU NP
  • 모델명 / 제조번호(시리얼번호)
    Batch No. 13011622, 13013239.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
  • 제품 설명
    NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. || Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
  • 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