Events

Rappel de OSTEONICS RESTORATION HIP SYSTEM - GAP ACETABULAR CUP PLATE SCREW

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
    75337
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-07-03
  • 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 that the third party supplier for material used to manufacture the cancellous bone screws and gap plate screw did not comply with metallurgical requirements outlined in the astm standards for titanium surgical implants. as such areas of modified material properties may result which may affect the intended use of the product. although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material the potential for variablity of the material used in manufacturing the affected lots could compromise the strength.

Device

OSTEONICS RESTORATION HIP SYSTEM - GAP ACETABULAR CUP PLATE SCREW
  • Modèle / numéro de série
    Model Catalog: 2080-0020 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0025 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0030 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0035 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0040 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0045 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0050 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0055 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0060 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6516 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6520 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6525 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6530 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6535 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6540 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6545 (Lot serial: > 10 NUMBE
  • Description du dispositif
    GAP PLATE SCREW
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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