Events

Rappel de Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer flex Gen.1- 3.14.251 Reaming shaft flex. Gen.1- 3.15.252 Countersink reamer flex. Gen.2- 3.14.256 Reaming shaft flex. 46-52 Gen.2- 3.14.257 Reaming shaft flex. 54-64 Gen.2- 3.14.258 Reaming shaft flex. 60-68 Gen.2- 3.14.259 Shaft flex. Gen.1- 3.40.501 Countersink reamer flex. Gen.3- 55.02.1901 Reaming shaft flex. Gen.3- 55.02.1903 seleXys Shaft flex- 5502.00.2 Shaft flex- 3.14.545

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Mathys Orthopaedics 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-2014-RN-00794-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-29
  • 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-2014-RN-00794-1
  • 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
    The validated process for the flexible shaft provides directions for a combined manual and mechanical cleaning/disinfection procedure. if the mandatory manual process as described in the processing instruction cannot be ensured/ performed, instruments by mathys ltd with flexible shafts may not be used. mathys ltd received feedback from hospitals that although the guidelines for processing and sterilising instruments were followed, residues on the instrument were still found. therefore mathys has developed an update to the processing instructions for the concerned instruments.
  • Action
    Mathys is notifying end users of the validated method for cleaning/disinfection of flexible shafts.

Device

Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer fl...
  • Modèle / numéro de série
    Surgical Instruments with flexible shaftsDescription & ArticleRM Classic Countersink reamer flex Gen.1- 3.14.251Reaming shaft flex. Gen.1- 3.15.252Countersink reamer flex. Gen.2- 3.14.256Reaming shaft flex. 46-52 Gen.2- 3.14.257Reaming shaft flex. 54-64 Gen.2- 3.14.258Reaming shaft flex. 60-68 Gen.2- 3.14.259Shaft flex. Gen.1- 3.40.501Countersink reamer flex. Gen.3- 55.02.1901Reaming shaft flex. Gen.3- 55.02.1903seleXys Shaft flex- 5502.00.2Shaft flex- 3.14.545
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd