Events

Rappel de Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

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
    RC-2016-RN-01468-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-09
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01468-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Stryker has received reports of two potential issues related to the offset cup reamer handle. the weld on the u-joint of the handle may become damaged over time, potentially causing the pin or pieces of the pin to fall into the wound. if that occurs, and the surgery proceeds with reaming, the pin or pieces of the pin may fall into the wound, which may be removed if visible or may be left in the wound. the handle also may not fully engage with the registration array and/or reamer basket. if that occurs, the surgery may proceed using a backup offset reamer handle, a straight reamer handle or manual instrumentation.
  • Action
    Customers are advised to inspect their inventory for affected product and quarantine it immediately. A Stryker representative will coordinate the return of any affected products. This action has been closed-out on 28/06/2017.

Device

Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Ace...
  • Modèle / numéro de série
    Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)Item Number: 207080All Lot Numbers affectedContained within trays: 151550, 151550-TARTG Number: 223107
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA