Events

Rappel de HOWMEDICA MODULAR RESECTION SYSTEM - PROXIMAL TIBIA

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
    40014
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2010-04-19
  • 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
    Stryker has become aware of an increased trend in the frequency of hmrs stem fractures which occur most often between the collar and the first screw hole on the stem. the fractures occurred when the anchorage stem was used in either the distal femur proximal femur or the proximal tibia. the anchorage stem can be used in either a fixed hinge or a rotating hinge knee construct. the root cause of this issue is that the labeling on the product is inadequate to preclude inappropriate patient selection for the device design.

Device

HOWMEDICA MODULAR RESECTION SYSTEM - PROXIMAL TIBIA
  • Modèle / numéro de série
    Model Catalog: 6367-4-013 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-011 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-019 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-017 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-112 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-015 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-014 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-013 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-115 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-114 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-113 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-111 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-014 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-015 (Lot serial: all lot/serial numbers);
  • Description du dispositif
    Stryker HMRS Anchorage Pieces
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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