Events

Rappel de Device Recall GDC 360 Detachable Coil

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
    73705
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1516-2016
  • Date de mise en oeuvre de l'événement
    2016-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144785
  • 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
    The incorrect dfu was packaged with two lots of gdc 360 degree detachable coils.
  • Action
    The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to. Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com

Device

Device Recall GDC 360 Detachable Coil
  • Modèle / numéro de série
    Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
  • Description du dispositif
    GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil || Sterile; || Model number: M0033471020SR0; || Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients 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