Events

Rappel de Bending/Cutting Pliers with Nose, for LOCK Plates 2.0

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-01359-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-23
  • 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-2014-RN-01359-1
  • 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 pliers have the potential for tip breakage while bending the extra-large compact 2.0 mandible locking plates (part numbers 447.412, 447.420, 447.422, 447.423, 447.424, 447.425, 447.426, 447.412s, 447.420s, 447.422s, 447.423s 447.424 s, 447.425 s and 447.426s ) with the last hole feature of the instrument.If a nonconforming bending/cutting pliers with nose for lock plates 2.0 is used and breaks while in the operating room, surgical delay may occur while alternate bending or cutting instruments are located.To date, there have been no reports of adverse events related to this issue. such reports are unlikely to occur as the bending/cutting pliers with nose for lock plates 2.0 are not used in direct contact with the patient but rather on the plates before they are inserted.
  • Action
    Customers are requested to:- 1. Check inventory immediately for the affected units; 2. Synthes will contact customers to arrange a replacement or credit as available; 3. An interim inspection procedure had been provided to customers whilst awaiting replacement stock. This action has been closed-out on 14/07/2016.

Device

Bending/Cutting Pliers with Nose, for LOCK Plates 2.0
  • Modèle / numéro de série
    Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Part Number: 329.143 Multiple Lot Numbers affectedARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd