Events

Rappel de Device Recall iovera Smart Tip

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 Myoscience Inc.

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
    71650
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2201-2015
  • Date de mise en oeuvre de l'événement
    2015-07-01
  • Date de publication de l'événement
    2015-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138539
  • 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, surgical, cryogenic - Product Code GXH
  • Cause
    The expiration date on the outer box label and the pouch label for the iovera smart tip product is incorrect. instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
  • Action
    Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.

Device

Device Recall iovera Smart Tip
  • Modèle / numéro de série
    Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
  • Description du dispositif
    iovera 155 Smart Tip; || Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) || iovera Smart Tips are individually packaged in Tyvek PET pouches, which are || then packaged into 5 or 10 pack boxes and shipper boxes. || Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue
  • Manufacturer
    Myoscience Inc

Manufacturer

Myoscience Inc
  • Adresse du fabricant
    Myoscience Inc, 46400 Fremont Blvd, Fremont CA 94538-6469
  • Société-mère du fabricant (2017)
    MyoScience Inc.
  • Source
    USFDA