Events

Rappel de Device Recall DURAGEN II DURAL REGENERATION MATRIX

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 Integra LifeSciences Corp.

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
    54253
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1081-2010
  • Date de mise en oeuvre de l'événement
    2010-01-13
  • Date de publication de l'événement
    2010-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87963
  • 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
    Dura substitute - Product Code GXQ
  • Cause
    One lot of suturable duragen dural regeneration matrix (# 1091575) did not pass stability testing at certain time points for suture retention strength and shrink temperature specifications.
  • Action
    An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.

Device

Device Recall DURAGEN II DURAL REGENERATION MATRIX
  • Modèle / numéro de série
    Catalog Number DURS3391; Lot number 1091575
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
  • Description du dispositif
    Suturable DuraGen Dural Regeneration Matrix; || Non-Pyrogenic; || Sterility guaranteed unless package is damaged or opened. Rx only. || Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 || Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp