Events

Rappel de CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic 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-00418-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-05-18
  • 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-00418-1
  • 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 incorrect label was applied to the product that is the subject of this action. certain lots of the chisel blades that were shipped to your facility may be labeled as “not for human use; for veterinary use only”.
  • Action
    The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were supplied may be labelled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY” This action has been closed-out on 03/03/2016.

Device

CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and s...
  • Modèle / numéro de série
    CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)Chisel Blade, long, width 10 mmP/N: 399.555Lot numbers: A7OA30, T921923, T933948 & 935423 Chisel Blade, long, width 16 mmP/N: 399.565Lot numbers: A7QA37 & T936951Chisel Blade, long, width 25 mmP/N: 399.575Lot numbers: A7OA36, T937762 & T966630P/N: 399.585Lot numbers: A7OA30 & T939691ARTG number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes