Events

Rappel de DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, Single

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

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-2015-RN-00184-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-05
  • 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-2015-RN-00184-1
  • 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 dhs/dcs impactor is composed of two parts: a replaceable plastic tip which is the insert for dhs/dcs impactor (338.260), and a metallic shaft (338.280). no biocompatibility testing has ever been completed by the manufacturer, synthes for the material (polyamide 6.6 with 20% carbon fibre reinforcement, tecamid 66 cf 20) for the insert and no evidence was found that it has been completed by other entities. potential for harm exists due to the potential for device breakage and may include surgical delay and adverse tissue reaction.
  • Action
    Johnson & Johnson Medical is replacing the plastic tip of the insert with a metal tip. Once the redesigned tip is available Johnson & Johnson Medical will arrange for the recovery and replacement of the old impactor tip. In the interim to ensure the impactor is available for emergency surgery, Johnson & Johnson Medical has provided end users with inspection instructions to check for any wear and tear. Alternatively, hospitals can return the tip for a credit note. This action has been closed out on 14 June 2017.

Device

DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, Single
  • Modèle / numéro de série
    DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, SinglePart number: 338.260All lot numbers below 7985313DHS/DCS & Impactor, for One-Step Insertion Technique, for No. 338.300Part number: 338.280All lot numbers below 8016184 ARTG number 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes