Events

Radiesse Injectable Implant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merz Aesthetics, 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
    58614
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2221-2011
  • 사례 시작날짜
    2011-04-06
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99710
  • 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
    Implant, dermal, for aesthetic use - Product Code LMH
  • 원인
    Merz aesthetics, inc. is recalling 1 lot (1034417) of radiesse 1.3 cc implant. the lot was supposed to be scrapped because it had failed to meet its loss on drying (lod) specification. unfortunately it had been marked as approved, released and shipped.
  • 조치
    The firm, Merz Aesthetics, Inc., contacted its consignee/customer via e-mail on April 6, 2011. The e-mail states the product, problem and action to be taken. The customer was instructed to follow up with the concerned and inform the status time to time to the Recall Coordinator. The product was confirmed to be quarantined and has been requested to be sent back. If you need any additional information regarding this issue or if you have any questions, contact the International Regulatory Affairs Specialist at 262-835-3300 ext. 3081.

Device

Radiesse Injectable Implant
  • 모델명 / 제조번호(시리얼번호)
    Lot 1024417
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    International only: Taiwan.
  • 제품 설명
    Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. || Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
  • Manufacturer
    Merz Aesthetics, Inc.

Manufacturer

Merz Aesthetics, Inc.
  • 제조사 주소
    Merz Aesthetics, Inc., 4133 Courtney Rd, Suite 10, Franksville WI 53126-9127
  • 제조사 모회사 (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA