METS Principal Shaft 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-2017-RN-01412-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-13
  • 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 has initiated a lot specific hazard alert. the mets product family of components are double pouched in polyamide/polyethylene (pa/pe) material and a box. during inspection, certain mets principal shafts were found to be missing the outer pouch. upon review, two additional principal shafts from the same lot were also discovered to be missing an outer pouch.
  • 조치
    Patients implanted with an affected lot number of the METS Principal Shaft should continue to be followed per the normal protocol established by his/her surgeon. Inform users of this Hazard Alert and forward this notice to all those individuals who need to be aware within your organisation. Complete the “Hazard Alert Notification Response” form, and return the form to Stryker electronically by email as directed.

Device

  • 모델명 / 제조번호(시리얼번호)
    METS Principal ShaftItem Number - msfshaft/150Lot Number - B10562ARTG Number: 246516 (Stryker Australia Pty Ltd - Femur/tibia shaft prosthesis)
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA