Events

DGDE, DirectGuide Drill Extender 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
    72549
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0396-2016
  • 사례 시작날짜
    2015-10-28
  • 사례 출판 날짜
    2015-12-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141502
  • 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
    Abutment, implant, dental, endosseous - Product Code NHA
  • 원인
    Implant direct sybron manufacturing, llc is recalling 26 lots of dgde directguide drill extender because of a possible dropping of the drill.
  • 조치
    On 10/28/15 customer notification letters were sent. Within the letter the firm states that if customers have any of the affected product listed to contact the firm's Customer Care at 1-888-649-6425. A return label is provided with notification. The firm states that if customers are an authorized Implant Direct Sybron Manufacturing distributor they request that they identify their customers that have been shipped the affected product, and contact them within 48 hours of receiving notification in order to obtain the product. The letter states if any customers or patients have experienced any issues as a result of the affected products to report the incident to the FDA through he MEDWATCH reporting system.

Device

DGDE, DirectGuide Drill Extender
  • 모델명 / 제조번호(시리얼번호)
    Parts Numbers: DGDE, SPCST, IBST, BST, CST, ICST, IBST, RBST, RCST   Lot Number: 61928, 64895, 64898, 64896, 65406, 65405, 65407, 65408, 65410, 65409, 65357, 67055, 67475, 67345, 37475, 67476, 67474, 67478, 67477, 67479, 67527, 68254, 68266, 68253, 68265, 68262
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution- US (nationwide) including the states of CA, FL, TX, MO, MI, MA, NV, OR, PA, AZ, IL, VA, OH, GA, and SC, and the country of Canada, Poland, Serbia, Italy, Germany, Cairo, Jordan, El Salvador, Kuwait, Costa Rica, Switzerland, Colombia, United Kingdom, Austria, Netherlands, Chile, and Egypt.
  • 제품 설명
    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
  • Manufacturer
    Implant Direct Sybron Manufacturing, LLC

Manufacturer

Implant Direct Sybron Manufacturing, LLC
  • 제조사 주소
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA