Events

Rappel de REJUVENATE MODULAR NECK 8 DEG.

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

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
    116682
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-06-29
  • 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
    Ongoing analysis of the global data following the product correction does not yield a significant increase in the global reported rate for adverse local tissue reaction (altr).However the additional data which includes variability in altr rates among sites may potentially be predictive of an increased likelihood of this condition for both the rejuvenate and abg ii modular hip systems. based on information received to date a product field action to remove these products is being conducted.

Device

REJUVENATE MODULAR NECK 8 DEG.
  • Modèle / numéro de série
    Model Catalog: NLV-340800G (Lot serial: ALL); Model Catalog: NLV-340800Y (Lot serial: ALL); Model Catalog: NLV-380800G (Lot serial: ALL); Model Catalog: NLV-380800Y (Lot serial: ALL); Model Catalog: NLV-420800G (Lot serial: ALL); Model Catalog: NLV-420800Y (Lot serial: ALL); Model Catalog: NLV-300800Y (Lot serial: ALL); Model Catalog: NLV-300800G (Lot serial: ALL); Model Catalog: NLS-421600P (Lot serial: ALL); Model Catalog: NLS-381600P (Lot serial: ALL); Model Catalog: NLS-341600P (Lot serial: ALL); Model Catalog: NLS-301600P (Lot serial: ALL); Model Catalog: SPT-120000S (Lot serial: ALL); Model Catalog: SPT-110000S (Lot serial: ALL); Model Catalog: SPT-100000S (Lot serial: ALL); Model Catalog: SPT-090000S (Lot serial: ALL); Model Catalog: SPT-080000S (Lot serial: ALL); Model Catalog: SPT-070000S (Lot serial: ALL); Model Catalog: NLS-420000B (Lot serial: ALL); Model Catalog: NLS-380000B (Lot serial: ALL); Model Catalog: NLS-340000B (Lot serial: ALL); Model Catalog: NLS-300000B (Lot serial: ALL)
  • Description du dispositif
    REJUVENATE MODULAR NECK 8 DEG.
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HC