Events

Device Recall CYTCOK TITANIUM POST SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dentsply Worldwide Headqrt 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
    51469
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1234-2009
  • 사례 시작날짜
    2009-03-20
  • 사례 출판 날짜
    2009-04-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-02-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80334
  • 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
    dental implant components - Product Code ELR
  • 원인
    The product is manufactured with a left-hand thread instead of a right hand thread. this error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.
  • 조치
    Dentsply notified their distributors and dentists of the recall by email sent on 03/20/2009 by Urgent Recall Notice letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter requests faxback response (enclosed with the recall notification) within five (5) working days. The letter included a response page to ensure the receipt of the notice. A second follow up letter will be sent to all that do not respond to the first letter. The firm identified another distributor within the company, DENTSPLY Tulsa Specialty Products, who also sent out identical recall letters to those they distributed the product on 03/25/09.

Device

Device Recall CYTCOK TITANIUM POST SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    C106KL0050A20 (12 posts), Packing Lot Numbers: 2045470, 2457580, 2725900, 2918670, 3032820, 3174500, 3328470, 3626480, and 3779590   C117K00000020 (4 posts), Packing Lot Numbers: 2660790, 3076090, 3231740, and 3797230
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia.
  • 제품 설명
    Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604
  • Manufacturer
    Dentsply Worldwide Headqrt

Manufacturer

Dentsply Worldwide Headqrt
  • 제조사 주소
    Dentsply Worldwide Headqrt, 221 W Philadelphia St Ste 6, York PA 17401-2992
  • 제조사 모회사 (2017)
    Dentsply Sirona Inc.
  • Source
    USFDA