Events

Rappel de PFNA Nails (used during internal fixation surgery)

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-01266-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-24
  • 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-01266-2
  • 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
    It was discovered that the above part and lot numbers may have the incorrect anodised colour. an implant with the incorrect anodised colour would not cause harm to the patient. if the user identifies the nonconformity during surgery, marginal surgical delay may occur while an alternate implant is located.
  • Action
    JJM is advising users to inspect and quarantine affected stock for return to JJM. This action has been closed-out on 05/09/2016. This action has been closed-out on 05/09/2016.

Device

PFNA Nails (used during internal fixation surgery)
  • Modèle / numéro de série
    PFNA Nails (used during internal fixation surgery)PFNA ø10 125° L240 TAN Part Number: 472.260S, Lot Number: 7913867PFNA ø11 125° L240 TAN Part Number: 472.261S, Lot Number: 2812685PFNA ø10 long r 125° L340 TAN Part Number: 472.275S, Lot Number: 2806520ARTG Number: 161140
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes