Events

Rappel de Nitinol Staples Elastic Staples - Large and Small Symmetrical

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LMT Surgical 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-2018-RN-00354-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-26
  • 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-2018-RN-00354-1
  • 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
    During a retrospective review of sterilisation records, trimed has determined that evidence of quarterly dose audits/verification required to comply with the relevant regulations could not be found. sterilization records indicate that all lots of staples were irradiated to at least the defined dose and although trimed has not received any reports of adverse events or injuries, there is a risk that this issue could result in patient infection if not properly sterilised.
  • Action
    As a permanent corrective action, TriMed will recall all of the Nitinol Staples that were manufactured between March 12, 2015 to the present date.

Device

Nitinol Staples Elastic Staples - Large and Small Symmetrical
  • Modèle / numéro de série
    Nitinol StaplesElastic Staples - Large and Small SymmetricalMultiple Model and Lot NumbersPanel Code: 87 Orthopedic, Part 888.3030Product Code: JDRAll staples manufactured between March 12, 2015 - presentARTG Number: 229705LMT Surgical - Fixation device, internal, staple
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd