Events

Device Recall Perioscopy Sheath 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Danville Materials, 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
    74533
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2530-2016
  • 사례 시작날짜
    2016-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147855
  • 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
    Unit, operative dental - Product Code EIA
  • 원인
    The perioscopy sheaths are currently provided with a label that indicates the sheath has a 3 year shelf-life/expiry date. danville materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
  • 조치
    Recall letters were sent on June 24 to Distributor OEM and customers by traceable delivery method. Letters informed customers of the issue and the affect part and lot numbers. Pro duct is to be quarantined and returned. Distributors are instructed to contact all customers and provide a copy of the recall letter. The response form should be completed and returned by each consignee.

Device

Device Recall Perioscopy Sheath
  • 모델명 / 제조번호(시리얼번호)
    Part number 1008: Lot numbers: 1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173; 1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1; 1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
  • 제품 설명
    Perioscopy Sheath: Part number: 1008; || The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
  • Manufacturer
    Danville Materials, Inc.

Manufacturer

Danville Materials, Inc.
  • 제조사 주소
    Danville Materials, Inc., 3420 Fostoria Way Ste A200, San Ramon CA 94583-1327
  • Source
    USFDA