PREMISE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kerr Corp 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
    49506
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0234-2009
  • 사례 시작날짜
    2008-09-05
  • 사례 출판 날짜
    2008-11-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    dental composite - Product Code EBF
  • 원인
    Material stiff: material in several lots of premise unidose appears to stiffen and become difficult to extrude over time.
  • 조치
    Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement

Device

  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBER(S): 2981430, 3001285, 3001286, and 3001288.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
  • 제품 설명
    PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite
  • Manufacturer

Manufacturer

  • 제조사 주소
    Kerr Corp, 1717 W Collins Ave, Orange CA 92867-5422
  • Source
    USFDA