Events

Rappel de SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    43409
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-08-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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:
  • Description du dispositif
    (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.