LFIT V40 Femoral Head 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia Pty 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
    RC-2015-RN-00129-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-24
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Stryker orthopaedics has received three customer complaints for a single lot of a specific size of the 32mm -4 v40 lfit vitallium femoral heads reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion. upon investigation it was found that the female taper of the femoral head was not machined per drawing specifications, leaving a lip protruding approximately 0.007in from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully assembling with the associated male stem trunnion.No adverse consequences or delays to surgery were reported for any of the three complaints.
  • 조치
    No additional patient follow-up or monitoring is required apart from usual routine follow-up, which will identify any issue. Symptomatic patients will present to their Health Care Practitioner. If any potential hazard or harms are detected by the Health Care Practitioner the appropriate action shall be taken. This action has been closed-out on 03/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    LFIT V40 Femoral HeadCatalogue Number: 62609032Lot Number: 48681201ARTG Number: 211868
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA