Events

Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 BioHorizons Implant Systems 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
    67090
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1058-2014
  • 사례 시작날짜
    2013-12-10
  • 사례 출판 날짜
    2014-02-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124682
  • 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, endosseous, root-form - Product Code DZE
  • 원인
    The body length of the external implant 40105d3 lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
  • 조치
    The firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to implants@biohorizons.com; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In addition, if you have already placed any affected implants without incident, no special patient action needs to be taken. If you have any questions regarding this information, please contact our Customer Care Department at (888) 246-8338, Monday through Friday, 7:30am to 6:00pm Central Time.

Device

Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 1302762, Exp 31 MAY 2018
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
  • 제품 설명
    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 || Usage: dental
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

BioHorizons Implant Systems Inc
  • 제조사 주소
    BioHorizons Implant Systems Inc, 2300 Riverchase Center, Birmingham AL 35244-2808
  • 제조사 모회사 (2017)
    Henry Schein Inc
  • Source
    USFDA