Events

SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC. 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
    43409
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-08-05
  • 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
    This recall is being initiated because the last hole on the veptr caudal rib supports subject to this recall may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation potential effects on the patient could also include pain loss of deformity correction and/or soft tissue/visceral injury.

Device

SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 497.231 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.230 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.229 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.228 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.227 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.226 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.225 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.249 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.248 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.247 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.100 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.099 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.098 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.246 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.245 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.244 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog:
  • 제품 설명
    (VEPTR) VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB CAUDAL RIB SUPPORTS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.