MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.) 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-2014-RN-01367-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-16
  • 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 become aware that there is a higher occurrence rate of implant damaged during intra-operative handling for the part number noted above. additionally, a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. post-operative harm is unlikely to be associated or identified with the use of the affected device.
  • 조치
    Stryker is informing all the MEDPOR barrier users of the issue and recalling the device. A Stryker Representative will contact the customer to arrange for product return and replacement. This action has been closed-out on 18/07/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)Catalogue Number: 9305Lot Numbers: A1312011, 77004 & 81799ARTG Number: 187178
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA