Events

Device Recall InterActive Implant OpenTray Transfer Narrow 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
    74208
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2046-2016
  • 사례 시작날짜
    2016-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146782
  • 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
    Tray, impression, preformed - Product Code EHY
  • 원인
    The incorrect sized product, interactive implant open-tray transfer wide, 6534-08w, was packaged instead of the interactive implant open-tray transfer narrow, 6534-08n, causing a possible issue with the impression. this discrepancy may lead to the possibility of an oversized crown fabrication.
  • 조치
    The firm sent out customer notificaiton letters on 05/19/16 via FedEx. Customers were asked to reivew the table to determine if they have any of the affected product in inventory. Customers were being informed that the proper product was being sent with the notificaiton. Customers were asked to complete and return the the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, the firm requests that they identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with the correct tool.

Device

Device Recall InterActive Implant OpenTray Transfer Narrow
  • 모델명 / 제조번호(시리얼번호)
    Lot #71664
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE
  • 제품 설명
    6534-08N InterActive¿ Implant Open-Tray Transfer Narrow || Part Number: 6534-08N || Product Usage: || Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the laboratory technician.
  • 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