Events

Device Recall Cannulated Drill Bit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Trilliant Surgical Ltd. 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
    71812
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2452-2015
  • 사례 시작날짜
    2015-07-20
  • 사례 출판 날짜
    2015-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139141
  • 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
    Bit, drill - Product Code HTW
  • 원인
    The cannulation of the 3.0/4.0 cannulated drill bit inner diamter is too small to allow for the guide wire to pass completely through.
  • 조치
    Trilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at orders@trilliantsurgical.com.

Device

Device Recall Cannulated Drill Bit
  • 모델명 / 제조번호(시리얼번호)
    Lot 1363-01
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
  • 제품 설명
    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System || The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
  • Manufacturer
    Trilliant Surgical Ltd.

Manufacturer

Trilliant Surgical Ltd.
  • 제조사 주소
    Trilliant Surgical Ltd., 6721 Portwest Dr Ste 160, Houston TX 77024-8019
  • Source
    USFDA