Events

Rappel de ASR 300 SIZE 44 ACETABULAR CUPS

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
    51219
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-08-26
  • 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
    Depuy issued a field safety notice in march 2010 (recall number 53553) after receiving data that demonstrated the asr system had a higher than expected revision rate at three years when used with smaller head sizes. new data now shows a higher than expected revision rate at five years across the entire size range. the manufacturer is therefore issuing a voluntary recall of all asr products.

Device

ASR 300 SIZE 44 ACETABULAR CUPS
  • Modèle / numéro de série
    Model Catalog: 999830754 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830752 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830750 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830748 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830746 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830744 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 9998-04-348 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-04-146 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-03-944 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-06-370 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-06-168 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-966 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-764 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-562 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-360 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-158 (Lo
  • Description du dispositif
    ASR 300 SPIKED ACETABULAR SHELLS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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