Events

Device Recall Silhouette Malar Implant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spectrum Designs 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
    38898
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1206-2007
  • 사례 시작날짜
    2007-06-15
  • 사례 출판 날짜
    2007-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54523
  • 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
    Malar Implant - Product Code LZK
  • 원인
    The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. this was discovered through a physician complaint.
  • 조치
    The firm initiated the recall on 06/15/2007 by contacting their customers by telephone. The firm followed-up by sending recall letters via FedEx or certified mail with signature confirmation to each direct account who received the recalled product on 06/18/2007.

Device

Device Recall Silhouette Malar Implant
  • 모델명 / 제조번호(시리얼번호)
    Lot number 30838, serial numbers BAE256 through BAE275, manufactured June, 2006. Expiration date is five years from date of manufacture.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide.
  • 제품 설명
    Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
  • Manufacturer
    Spectrum Designs Inc

Manufacturer

Spectrum Designs Inc
  • 제조사 주소
    Spectrum Designs Inc, 6387 B Rose Lane, Carpinteria CA 93013
  • 제조사 모회사 (2017)
    Spectrum Designs Inc
  • Source
    USFDA