Events

STEP DRILL 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 IMPLANT DIRECT SYBRON MANUFACTURING LLC 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
    32385
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-11-03
  • 사례 국가
    Canada
  • 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
    Implant direct sybron manufacturing llc is recalling 3 lots of the dgde directguide drill extender (dgde) and 22 lots of associated products that contain dgde as an accessory. through internal regulatory affairs evaluation (hhe) process company found a possible safety issue with the retention of the drill when the dgde is in use. this discrepancy may lead to the possibility of the dgde dropping the drill. the company's current data indicates the possibility of this occurring is unlikely (0.69%).

Device

STEP DRILL
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: SPCST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: IBST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: DGDE (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: BST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: RBST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: ICST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: CST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: RCST (Lot serial: >10 NUMBERS CONTACT MFG.)
  • 제품 설명
    DGDE- DIRECTGUIDE DRILL EXTENDER
  • Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC

Manufacturer

IMPLANT DIRECT SYBRON MANUFACTURING LLC