Events

Device Recall Herbst Universal Nut 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Specialty Appliance Works, 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
    70787
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1502-2015
  • 사례 시작날짜
    2015-03-09
  • 사례 출판 날짜
    2015-04-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134676
  • 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
    Clamp, wire, orthodontic - Product Code ECN
  • 원인
    The universal nut, a component of the orthodontic herbst appliance was made with 416 ss and not the specified 303 ss.
  • 조치
    Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.

Device

Device Recall Herbst Universal Nut
  • 모델명 / 제조번호(시리얼번호)
    1405016
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
  • 제품 설명
    Herbst Universal Nut which is used in a Herbst Appliance || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
  • Manufacturer
    Specialty Appliance Works, Inc.

Manufacturer

Specialty Appliance Works, Inc.
  • 제조사 주소
    Specialty Appliance Works, Inc., 4905 Hammond Industrial Dr, Cumming GA 30041-3914
  • 제조사 모회사 (2017)
    Specialty Appliance Works, Inc.
  • Source
    USFDA