INFUSE BONE GRAFT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MEDTRONIC OF CANADA 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
    24947
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-06-13
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Product associated with a voluntary recall being conducted by integra lifesciences corporation. specifically integra life sciences corporation has recalled certain lots of the absorbable collagen sponge (acs) which is a component of the infuser bone graft kit. integra lifesciences corporation announced the voluntary recall advising us as follows: "integra life sciences has identified through an internal quality assurance review of processes that we may have deviated from a production process during the manufacture of specific lots of product. accordingly we are recalling those specific lots. the product lots in question passed all product finished goods testing are sterile and were tested and accepted for endotoxin levels. however due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. we are not aware of any reports of patient injuries or other adverse events in connection with these product lots. however if you have already implanted or used collagen sponge products affected by this recall we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol.".

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7510200 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510400 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510800 (Lot serial: > 10 lot numbers contact mfg)
  • 제품 설명
    INFUSE BONE GRAFT
  • Manufacturer

Manufacturer

  • 제조사 주소
    BRAMPTON
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC