Events

Rappel de JTS Drive Unit

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-2017-RN-00865-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-19
  • 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-00865-1
  • 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
    Stryker has received three complaints regarding the jts drive unit. these relate to the potential for utilisation of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device and the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.New labelling is to be provided, and a quick start guide attached to the device, along with revisions to the limb lengthening protocol & operation manual to reference these labelling modifications. these modifications/ updates are to clarify the correct orientation in relation to the limb entry point of the device.
  • Action
    Stryker is requesting: 1. Users of this Medical Device forward the supplied notice to all those individuals who need to be aware within their organisation; 2. Inspect inventory for the impacted JTS Drive Unit and quarantine it immediately; 3. Contact their local Stryker representative to coordinate the return of any affected product you may have; 4. Complete the supplied “Medical Device Recall Notification Response” form even if they do not have any affected product. Return the form to Stryker by fax on (02) 9467 1325 or electronically via email to recalls@stryker.com; 5. If any affected stock could have been transferred from their hospital to another location, please immediately let them know of this recall and notify Stryker 6. If customers have disposed of any affected units, provide the item and lot numbers of the disposed product to Stryker via email account recalls@stryker.com.

Device

JTS Drive Unit
  • Modèle / numéro de série
    JTS Drive UnitItem Number: MLE3All LotsARTG Number: 233532
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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