Events

Rappel de GDC10 360 10mm x 30cm SR ;

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Neurovascular.

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
    69669
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0479-2015
  • Date de mise en oeuvre de l'événement
    2014-10-22
  • Date de publication de l'événement
    2014-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131299
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Device, neurovascular embolization - Product Code HCG
  • Cause
    Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
  • Action
    Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters request that users take the following actions: 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: a. Fax it to: 1-866-876-4355 or b. E-mail a copy to: NeuroComplaints@stryker.com c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Stryker Customer Service reps will contact customers to arrange for replacement. Any returned product will be quarantined and destroyed.

Device

GDC10 360 10mm x 30cm SR ;
  • Modèle / numéro de série
    Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of: VA, NH, OH and TX.
  • Description du dispositif
    GDC-10 360 10mm x 30cm SR ; || GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's || general medical condition - are considered by the treating neurosurgical team to be || a) very high risk for management by traditional operative techniques, or b) inoperable
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Adresse du fabricant
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA