Events

Device Recall ImplantDirect simply InterActive Implant, Part 655010U 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Implant Direct Sybron Manufacturing, 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
    79793
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1917-2018
  • 사례 시작날짜
    2018-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163452
  • 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
    The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
  • 조치
    The recall letter dated 3/16/2018 was first issued via email to one of the foreign consignees on 3/14/2018. The U.S. and other foreign consignees were mailed letters on 3/16/2018 via FedEx overnight mail. the letter identified the affected product, problem and actions to be taken.

Device

Device Recall ImplantDirect simply InterActive Implant, Part 655010U
  • 모델명 / 제조번호(시리얼번호)
    Lot #68960
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.
  • 제품 설명
    ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. || Product Usage: Usage: || Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
  • Manufacturer
    Implant Direct Sybron Manufacturing, LLC

Manufacturer

Implant Direct Sybron Manufacturing, LLC
  • 제조사 주소
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Thousand Oaks CA 91362
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA