Events

Device Recall Opal Orthodontics by Ultradent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ultradent Products, 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
    66978
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0481-2014
  • 사례 시작날짜
    2013-11-19
  • 사례 출판 날짜
    2013-12-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124400
  • 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
    Bracket, ceramic, orthodontic - Product Code NJM
  • 원인
    Ultradent products inc. is recalling various lots of avex cx2 orthodontic brackets because the design control process was not complete prior to distribution.
  • 조치
    Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420.

Device

Device Recall Opal Orthodontics by Ultradent
  • 모델명 / 제조번호(시리얼번호)
    R&D; Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
  • 제품 설명
    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets || Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • 제조사 주소
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
  • 제조사 모회사 (2017)
    Ultradent Products Inc
  • Source
    USFDA