Events

Device Recall Spectrum Designs MedicalNasal Dorsal Columella 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
    44735
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1264-2007
  • 사례 시작날짜
    2007-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64329
  • 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
    Nasal Dorsal Columella Implant, - Product Code LZK
  • 원인
    Mispackaging/mislabeling: a portion of packaged nasal lot 31053 contained chin implants instead of the nasal implant.
  • 조치
    The firm initiated the recall on 07/24/2007 by contacting the customer (distributor) who filed the original complaint of mislabeling by email. The firm followed-up by sending recall letters (dated July 24, 2007) via FedEx or certified mail with signature confirmation to the one other direct account who received the recalled product on 08/03/2007. Customers were instructed to check their inventory for mislabeled products and call Spectrum at (800)239-6399 to report the number of this product being returned. They were given an address for product return. The firm indicated they will examine returned products, and scrap after examination.

Device

Device Recall Spectrum Designs MedicalNasal Dorsal Columella Implant
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide: California and China
  • 제품 설명
    Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655
  • Manufacturer
    Spectrum Designs Inc

Manufacturer

Spectrum Designs Inc
  • 제조사 주소
    Spectrum Designs Inc, 6387 Rose Ln Ste B, Carpinteria CA 93013-2937
  • Source
    USFDA