Events

Rappel de Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short Attachments

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes Australia Pty Ltd.

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-2014-RN-00040-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-22
  • 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-2014-RN-00040-1
  • 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
    Laser marking location is out of specification (i.E., greater than 2.00 inches from the distal end of the cutting burr). fracture of the carbide cutting bur could occur if short cutting burrs with an out of specification laser location were used with an attachment that may have worn bearings. cutter fracture could result in user laceration, re-operation due to remaining fragments, soft tissue damage due to fragment retrieval, and delay in surgery.
  • Action
    Synthes is advising users to return affected units.

Device

Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with ...
  • Modèle / numéro de série
    Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short AttachmentsPart Number: S-15DRMCMultiple lot numbers affectedARTG Number: 141597
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd