Events

Device Recall Sleeve Installation Tool Instrument 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 OrthoPediatrics Corp 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
    69050
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2560-2014
  • 사례 시작날짜
    2014-07-25
  • 사례 출판 날짜
    2014-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129442
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • 원인
    Weld fractures on the sleeve installation tool for acl reconstruction system.
  • 조치
    OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .

Device

Device Recall Sleeve Installation Tool Instrument
  • 모델명 / 제조번호(시리얼번호)
    Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm || Product Usage: || The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • 제조사 주소
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • 제조사 모회사 (2017)
    Orthopediatrics Corp
  • Source
    USFDA