Events

Rappel de Acetabular Cup Introducer (32mm)

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-2017-RN-01385-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-03
  • 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-2017-RN-01385-1
  • 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
    Johnson & johnson medical (jjm) has identified an issue with the acetabular cup introducer (32mm) where the nylon ejector slug may melt during the autoclave process. this may cause the ejector to be inoperable and the cup introducer to be difficult to remove after cup placement.
  • Action
    JJM is requesting Customers: 1. Immediately inspect the device(s) in your possession to determine if your facility has affected product. If you do please quarantine this product prior to returning it to JJM; 2. Return a copy of the supplied acknowledgement form, even if you do not have any affected product, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com; 3. Return any affected product as soon as possible, but within 30 business days, by contacting JJM Customer Service on 1300 562 711; 4. Forward the recall notice to anyone in your facility who needs to be informed; and 5. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).

Device

Acetabular Cup Introducer (32mm)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes