Events

Rappel de Stryker burs: Round Fluted Soft Touch 3.omm, Neuro Drill 3.0mm, Round Fluted Bur 1.0mm

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Stryker Instruments.

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
    16763
  • Date de mise en oeuvre de l'événement
    2014-05-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    The manufacturer advises that in approx 1:1000 cases the not feature of the product is only partically present or is entrely missing. . "missing notches" indicates that there are fewer than the normally expected number of notches. "partial notches" indicates that one notch is incomplete because it was begun too close to the end of the shank to allow for a full width notch. a product with "no notches" will have a smooth shank, with no notching.
  • Action
    Product to be exchanged

Device

Stryker burs: Round Fluted Soft Touch 3.omm, Neuro Drill 3.0mm, Round Fluted Bur 1.0mm
  • Modèle / numéro de série
    Model: Models: 5820010130, 5820107030, 5820010010, Affected: Lots, 13346027, 14007017 & 13351017, 14005017
  • Manufacturer
    Stryker Instruments

Manufacturer

Stryker Instruments
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA