Events

Device Recall NuOss XC Sinus 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Collagen Matrix 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
    73206
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1097-2016
  • 사례 시작날짜
    2013-05-13
  • 사례 출판 날짜
    2016-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143566
  • 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
    Bone grafting material, animal source - Product Code NPM
  • 원인
    During the 36 month real time shelf life testing of nuoss xc sinus (bmcu-umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
  • 조치
    The firm, Collagen Matrix Inc., sent an email dated May 14, 2013 to its sole customer. The email described the product, problem and actions to be taken. The customer was instructed to return all product with expiration dates 12/2014 or earlier under Returned Goods, the firm will replace these products with new inventory; and return to Collagen Matrix, Inc., 15 Thornton Road, Oakland, NJ 07436 or quarantine products with expiration date 1/2016 until further notice. If you have any questions,call 201-405-1477 x 304 or email: www.collagenmatrix.com.

Device

Device Recall NuOss XC Sinus
  • 모델명 / 제조번호(시리얼번호)
    Lot BMCXU11P1. BMCXU11H3  Lot BMCXU11P1, BMCXU12P1
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to state of: MA.
  • 제품 설명
    NuOss XC Sinus || Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) || Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) || Manufacturer:- Collagen Matrix, || Distributor:- ACE Surgical Supply Co, Inc, || Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
  • Manufacturer
    Collagen Matrix Inc

Manufacturer

Collagen Matrix Inc
  • 제조사 주소
    Collagen Matrix Inc, 509 Commerce St, Franklin Lakes NJ 07417-1374
  • 제조사 모회사 (2017)
    Collagen Matrix Inc.
  • Source
    USFDA