Events

Rappel de Stryker Torque Wrench

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 Spine SAS.

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
    16051
  • Date de mise en oeuvre de l'événement
    2014-01-22
  • 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
    Manufacturer previously initiated a lot specific recall (ref #15444) after reports received that the hex tip of the torque wrench of an identified lot number subset had been fracturing during final tightening.The establised cause for the fracture was due to grain boundary attack as a result of the heat treat process. since that time additional testing has continued and the manufacturer has made the decision to distribute a recall letter to all customers that have a procedure pack in their possession that may contain the affected product and inform them of the recall expansion. additionally the manufacturer has confirmed that the supplier will use a new heat treatment vendor for which there is a validated heat treatment process., 31/07/2015 - identified that lot 11e035 was not previous included in the recall letters associated with this recall. recall letter updated to include all affected lots and attached a list of all current locations.
  • Action
    Product to be returned to supplier

Device

Stryker Torque Wrench
  • Modèle / numéro de série
    Model: Xia 03807028, Xia 3 48237028, Mantis Redux 48287028, Affected: 092793, 098525, 11A957, 11E035, 11E039, 11E042, 11E045, 11E046, 11E047 , 123746, 127051 and R11E036
  • Manufacturer
    Stryker Spine SAS

Manufacturer

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