Events

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Highland Metals, 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
    67378
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0923-2014
  • 사례 시작날짜
    2013-12-13
  • 사례 출판 날짜
    2014-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125381
  • 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
    Wire, orthodontic - Product Code DZC
  • 원인
    Labeling issue: product labeled as "upper" may contain "lower" archwires with a red midline mark. product labeled ad "lower" may contain "upper" archwires with a black midline mark.
  • 조치
    Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to quality@highlandmetals.com. For questions regarding this recall call 408-271-2955.

Device

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.
  • 모델명 / 제조번호(시리얼번호)
    Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
  • 제품 설명
    SuperElastic Regular force NiTi lower or upper Natural arches. || 0.14 size || 10 or 100 count packages. || Highland Metals Inc. || San Jose, CA || The devices are intended to provide force to the teeth to effect movement in order to alter their position.
  • Manufacturer
    Highland Metals, Inc.

Manufacturer

Highland Metals, Inc.
  • 제조사 주소
    Highland Metals, Inc., 419 Perrymont Ave, San Jose CA 95125-1445
  • Source
    USFDA