Events

Rappel de ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

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
    142920
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-27
  • 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
    Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. recurrence / reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh flexible composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. ethicon is unable at this time to characterize all factors contributing to higher rates and is therefore removing the product from the global market.

Device

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Modèle / numéro de série
    Model Catalog: PHY3050R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY3035R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2535V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2030R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY0715R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1515Q (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1015V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2025V (Lot serial: >100 NUMBERS (ALL LOTS))
  • Description du dispositif
    PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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