Events

Device Recall PrimaConnex Implant System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Keystone Dental 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
    79040
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0608-2018
  • 사례 시작날짜
    2017-06-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-04-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161223
  • 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
    Abutment, implant, dental, endosseous - Product Code NHA
  • 원인
    Abutments are unable to accept the final abutment screw.
  • 조치
    On June 20, 2017 Keystone Dental telephoned impacted customers and advised them of the problem. On July 3rd, 2017 Keystone Dental issued notices (dated June 29, 2017) and response forms to customers via Fed Ex. Customers were encouraged to complete and return the response form attached form to confirm receipt of the replacement product and that lot 33006 can be returned to Keystone Dental. Customers with questions can call Johanna Drzyzga, Customer Relations Manager at 866-902-9272.

Device

Device Recall PrimaConnex Implant System
  • 모델명 / 제조번호(시리얼번호)
    REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of ND, NJ & MA
  • 제품 설명
    Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K || pRODUCT Usage: || Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
  • Manufacturer
    Keystone Dental Inc

Manufacturer

Keystone Dental Inc
  • 제조사 주소
    Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
  • 제조사 모회사 (2017)
    Keystone Dental Inc
  • Source
    USFDA