Events

Rappel de Synthes Insert for DHS/DCS Impactor No. 338.260, single

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 Synthes GmbH.

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
    18229
  • Date de mise en oeuvre de l'événement
    2015-03-25
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • 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 which may include surgical delay and adverse tissue reaction.
  • Action
    Product to be exchanged

Device

Synthes Insert for DHS/DCS Impactor No. 338.260, single
  • Modèle / numéro de série
    Model: Part Number: 338.260, Affected: All lots below 7985313
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH