COCR DYNAMIC LOCKING SCREW SELF TAPPING 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SYNTHES (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
    45089
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-06-25
  • 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
    Synthes (canada) ltd. is initiating a voluntary recall of all lots of the 3.7mm and 5.0mm dynamic locking screw (dls). the voluntary recall is being initiated following synthes' receipt of customer complaints of 3.7 and 5.0 mm dls breakages at the distal tip of the pin identified after successful healing and during planned implant removal of the whole construct. there have been no reports of permanent impairment associated with the reason for this recall to date. however synthes is aware that significant elongation of surgical time has occurred in planned implant removals which involved a broken dls screw.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 09.213.022S (Lot serial: all lots); Model Catalog: 09.223.090S (Lot serial: all lots); Model Catalog: 09.223.085S (Lot serial: all lots); Model Catalog: 09.223.080S (Lot serial: all lots); Model Catalog: 09.223.075S (Lot serial: all lots); Model Catalog: 09.223.070S (Lot serial: all lots); Model Catalog: 09.223.065S (Lot serial: all lots); Model Catalog: 09.223.060S (Lot serial: all lots); Model Catalog: 09.223.058S (Lot serial: all lots); Model Catalog: 09.223.056S (Lot serial: all lots); Model Catalog: 09.223.055S (Lot serial: all lots); Model Catalog: 09.223.054S (Lot serial: all lots); Model Catalog: 09.223.052S (Lot serial: all lots); Model Catalog: 09.223.050S (Lot serial: all lots); Model Catalog: 09.223.048S (Lot serial: all lots); Model Catalog: 09.223.046S (Lot serial: all lots); Model Catalog: 09.223.044S (Lot serial: all lots); Model Catalog: 09.223.042S (Lot serial: all lots); Model Catalog: 09.223.040S (Lot serial: all lots); Model Catalog: 09.223.038S (Lot serial: all lots); Mod
  • 제품 설명
    COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Manufacturer

Manufacturer