Events

Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sybron Dental Specialties 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
    70551
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1291-2015
  • 사례 시작날짜
    2015-02-11
  • 사례 출판 날짜
    2015-03-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134019
  • 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
    Cover, barrier, protective - Product Code MMP
  • 원인
    Cases of cure sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. there is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
  • 조치
    The firm sent out letters to customers on 02/11/15. The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number. The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification. The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.

Device

Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 4513C or 4513-1.  Lot Number: 2014030110
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
  • 제품 설명
    Outer cardboard box labeling: || Pinnacle Cure Sleeve, Curing Light Tip Sleeves. || Kerr Total Care. || Part Number: 4513C or 4513-1 || Single Patient Use || Fits 13mm Tips. Pack of 400. || Metrex Research, Manufacturer. || Inner individual packaging of each sleeve: || Cure Sleeve by Pinnacle || Model 4500
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • 제조사 주소
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA