Events

Alpen Carbide 702 Cross Cut Tapered Fissure 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Coltene Whaledent Inc 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
    79994
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1883-2018
  • 사례 시작날짜
    2018-04-13
  • 사례 출판 날짜
    2018-05-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164149
  • 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
    Bur, dental - Product Code EJL
  • 원인
    The products are labeled with an incorrect product number.
  • 조치
    Customers were contacted via telephone call on 4/13/18. The customers were asked the following questions: 1. Confirm that {name of Distributor} received {number of packs} around this date {date}. 2. Confirm that the affected product, lot number I37460, is still in their inventory. a. If not, to whom was it shipped to? [Coltene will need that contact information]. 3. Can you take a picture of the lot number I37460 that you received and send to {Regional sales manager}? 4. Please return the product in question to Coltene per Vendor Return Authorization with full tracking information.

Device

Alpen Carbide 702 Cross Cut Tapered Fissure
  • 모델명 / 제조번호(시리얼번호)
    Batch I37640
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
  • 제품 설명
    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
  • Manufacturer
    Coltene Whaledent Inc

Manufacturer

Coltene Whaledent Inc
  • 제조사 주소
    Coltene Whaledent Inc, 235 Ascot Pkwy, Cuyahoga Falls OH 44223-3701
  • 제조사 모회사 (2017)
    Coltene Holding AG
  • Source
    USFDA