Events

Rappel de Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile

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-2016-RN-01645-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-23
  • 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-2016-RN-01645-1
  • 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 expiration date on the label for the referenced products is incorrect. existing testing supports an expiration date of 2 years from manufacturing. the affected products on the market were labelled with an expiration date of 10 years. there is biocompatibility test data to support an expiration date 2 years only.Use of this product beyond its expiry date of 2 years poses a theoretical risk of an adverse tissue reaction in the event the device develops cytotoxicity and/or infection.
  • Action
    Johnson & Johnson Medical (JJM) is requesting users Immediately inspect the device(s) in their possession to determine if your facility has affected product. In the event defective product is identified please quarantine these units prior to returning them to JJM. Return a copy of the completed acknowledgement form, even if no affected product is identified, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com

Device

Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Sh...
  • Modèle / numéro de série
    Trauma RIA (Reamer/Irrigator/Aspirator) SystemPart Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterilePart Number : 314.746SLot Numbers: 2251446-I, 2256902-I, 2256903-I, 2256904-I, 2256905-I, 2256906-I, 2256907-IARTG Number: 157016
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes