Events

Rappel de DYNASTY ACETABULAR SYSTEM - POROUS SHELL BF SHELL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par WRIGHT MEDICAL TECHNOLOGY CANADA LTD.

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
    15523
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-04-12
  • 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
    As a result of a field complaint wright medical technology inc. began an investigation of the dynasty biofoam sterile packagin spacer that appeared to be shaving off during transit. the possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.

Device

DYNASTY ACETABULAR SYSTEM - POROUS SHELL BF SHELL
  • Modèle / numéro de série
    Model Catalog: DSBFGH66 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGG62 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGJ70 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGJ72 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGJ74 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGK76 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGG60 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGG58 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGF56 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGE54 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGB46 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGD52 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGC50 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGB48 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGH64 (Lot serial: >100 numbers contact mfg); Model Catalog: DSBFGH68 (Lot serial: >100 numbers contact mfg)
  • Description du dispositif
    DYNASTY BIOFOAM SHELL
  • Manufacturer
    WRIGHT MEDICAL TECHNOLOGY CANADA LTD

Manufacturer

WRIGHT MEDICAL TECHNOLOGY CANADA LTD