Events

Rappel de K-Wires for T2 and Gamma Systems (Internal fixation wire)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-2016-RN-01469-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-10
  • 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-01469-1
  • 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
    Through a review of packaging, stryker has identified that the seal integrity of the pouch may be compromised. more specifically, there is a potential that the sterile pouch may not be sealed at one end due to a manufacturing error. a missing seal could potentially lead to unsterile product. risk mitigating factors include that the non-conformance is obvious to the user. surgical guidelines outline inspection of the sterile barrier (seal) for sterile packed medical devices prior to use. the pouch itself shows a note: “contents sterile unless this package has been damaged or opened.” the secondary packaging is a (plastic) clear tube with silicone caps at both ends. while not validated as a sterile barrier, it does provide additional protection to the enclosed pouch package configuration. no injury or harm has been reported regarding this issue.
  • Action
    Customers are asked to inspect their inventory for affected products and quarantine any affected items immediately. A Stryker representative will coordinate the return of any affected product and supply unaffected ones where necessary. This action has been closed-out on 28/06/2017.

Device

K-Wires for T2 and Gamma Systems (Internal fixation wire)
  • Modèle / numéro de série
    K-Wires for T2 and Gamma Systems (Internal fixation wire) GAM Kirschner WireItem Number: 12106450ST2 K-WireItem Number: 18060050S T2 K-Wire ReconItem Number: 18063030S Multiple Lot Numbers affectedARTG Number: 143230
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA