Device Recall Zimmer Natural Nail System, Antegrade Femoral Interlock Module 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer 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
    52806
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0385-2010
  • 사례 시작날짜
    2009-07-01
  • 사례 출판 날짜
    2009-11-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • 원인
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • 조치
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 61227882.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • 제품 설명
    Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-03. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA