Rappel de RADIAL BROACH ASSY

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
    94659
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-10-17
  • Pays de l'événement
  • 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
    The result of an audit review [conducted during the month of august 2017] of the currently available data of the stryker rhead radial head and uni-elbow system was found to be inconclusive to continue supporting the performance of the device. consequently stryker has decided to remove the product from the global markets.

Device

  • Modèle / numéro de série
    Model Catalog: 17-0974 (Lot serial: ALL); Model Catalog: 17-0954 (Lot serial: ALL); Model Catalog: 17-0953 (Lot serial: ALL); Model Catalog: 17-0952 (Lot serial: ALL); Model Catalog: RCN-S2 (Lot serial: ALL); Model Catalog: 17-0929 (Lot serial: ALL); Model Catalog: 17-0992 (Lot serial: ALL); Model Catalog: RCN-S4 (Lot serial: ALL); Model Catalog: RCN-S3 (Lot serial: ALL); Model Catalog: 17-0967 (Lot serial: ALL); Model Catalog: RCN-H4 (Lot serial: ALL); Model Catalog: 9230100 (Lot serial: ALL); Model Catalog: RCN-H2 (Lot serial: ALL); Model Catalog: 17-0948 (Lot serial: ALL); Model Catalog: 17-0947 (Lot serial: ALL); Model Catalog: 17-0946 (Lot serial: ALL); Model Catalog: RHA-H4 (Lot serial: ALL); Model Catalog: RHA-H3 (Lot serial: ALL); Model Catalog: RHA-H2 (Lot serial: ALL); Model Catalog: RHA-S4 (Lot serial: ALL); Model Catalog: RHA-S3 (Lot serial: ALL); Model Catalog: RHA-S2 (Lot serial: ALL); Model Catalog: 17-0972 (Lot serial: ALL); Model Catalog: 17-0951 (Lot serial: ALL); Model Catalog: 17-0950 (Lo
  • Description du dispositif
    RADIAL BROACH ASSY;RECON - RADIAL IMPLANT - STANDARD;RESECTION GUIDE RHEAD;RHEAD RECON ASSEMBLY TOOL;RECON - RADIAL IMPLANT - HEAD;RHEAD EXTENDED STEM AWL;STANDARD HEAD TRIAL;RHEAD RADIAL IMPLANT HEAD;RHEAD RADIAL IMPLANT STANDARD STEM;STANDARD STEM TRIAL
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
  • Source
    HC