Events

Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Surgical Specialties 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-00233-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00233-1
  • 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
    An investigation was completed following a complaint by a surgeon that the ceramic femoral head was shorter by 2mm than other 36mm microport femoral heads. microport's investigation confirmed this complaint and concluded that the microport 36mm ceramic femoral heads have been manufactured to this specification for over 15 years. the main complaint issue associated with this finding would be surgical revision for dislocation or laxity of the hip joint.
  • 조치
    Surgical Specialties is advising surgeons to maintain their usual follow-up protocol and actions for their patients and to ensure that these patients are informed about symptoms (particularly pain, instability, difficulty walking and/or performing common tasks) that indicate the need for revision surgery.

Device

Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck
  • 모델명 / 제조번호(시리얼번호)
    Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short NeckPart Number: 26000010 Ceramic Femoral Head 36mm SLT Taper Medium NeckPart Number: 26000011Ceramic Femoral Head 36mm SLT Taper Long NeckPart Number: 26000012
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd