Events

Rappel de TRIATHLON TIBIAL ALIGNMENT HANDLE

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
    45981
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-10-12
  • 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
    Stryker received a product experience report (per) that a swivel block was improperly oriented on a triathlon tibial alignment handle. the locator holes on the alignment guide handle on which the swivel block is mounted are not in alignment as per print. the tibial alignment handle was not machined properly on the 5 axis machine because the tibial alignment handle was not fixtured properly on the machine by the operator. the fixturing procedure involved manually locating every part in a collet aligning datum c using a square and locking the part in position for machining of the slot and cross hole. additionally the particular feature was not inspected during in-process and/or final inspection at the vendor. hence the non-conformance was not detected.

Device

TRIATHLON TIBIAL ALIGNMENT HANDLE
  • Modèle / numéro de série
    Model Catalog: I-K2072AHOO (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6541-2-807 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6541-2-808 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    TRIATHLON TIBIAL ALIGNMENT HANDLE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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