Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic procedures 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-2013-RN-00285-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-03-28
  • 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
    There is an update to the instructions for use (ifu) to reflect that blue free strand orthocord® sutures are expected to retain 80% of their original strength at six weeks after implantation, instead of 100% as indicated in the current ifu.
  • 조치
    Updating the Instructions for Use (IFU)

Device

  • 모델명 / 제조번호(시리얼번호)
    Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic proceduresProduct codes: 223111, 223113, 223114, 223115 & 223116ARTG Numbers: 121837 & 121836
  • Manufacturer

Manufacturer