Events

nanOss Bioactive 10cc Bone Void Filler 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 RTI Surgical 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-01005-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-08-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01005-1
  • 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
    Rti surgical has been advised that a specific batch of nanoss bioactive 10cc bone void filler was shipped at the incorrect revision.Although the revision of the product as a whole (implant, accessories, packaging, labelling) was rev a instead of rev b, the implant itself remained unchanged and is safe. the changes included removal of an accessory syringe provided for rehydration, and minor changes to the labelling and ifu. no changes between revisions impact patient safety.To date, there have been zero complaints, as this issue was found internally only.
  • 조치
    RTI Surgical is requesting customers inspect their stocks and quarantine all units from the affected batch number. Complete the supplied Customer Acknowledgement Form and return it via email to RTI Surgical so that they may arrange for your stock to be recovered and for replacement stock, or a credit note to be issued. Complete the supplied Customer Acknowledgement Form even if you have no stock which is subject to this recall action as RTI Surgical requires this information to reconcile this process.

Device

nanOss Bioactive 10cc Bone Void Filler
  • 모델명 / 제조번호(시리얼번호)
    nanOss Bioactive 10cc Bone Void FillerCatalogue Number: 90-100-10ELot Number: 257592Expiry: 10/03/2018ARTG Number: 279230
  • Manufacturer
    RTI Surgical Australia Pty Ltd

Manufacturer

RTI Surgical Australia Pty Ltd
  • Source
    DHTGA