Events

RBT, Internal Implant, LaserLok, 5.0 x 15mm, 5.7 Platform 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
    72598
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0391-2016
  • 사례 시작날짜
    2015-10-30
  • 사례 출판 날짜
    2015-12-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141630
  • 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
    An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
  • 조치
    BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to lpbr5015@biohorizons.com. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205.

Device

RBT, Internal Implant, LaserLok, 5.0 x 15mm, 5.7 Platform
  • 모델명 / 제조번호(시리얼번호)
    Lot 1404442
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
  • 제품 설명
    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), || Dental Implant
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

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