Events

Rappel de Device Recall Integra

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
    70758
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1452-2015
  • Date de mise en oeuvre de l'événement
    2015-03-13
  • Date de publication de l'événement
    2015-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-04-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134614
  • 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
    Dressing, wound, collagen - Product Code KGN
  • Cause
    A lot of flowable wound matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).
  • Action
    Integra Life Sciences Inc. sent a Recall letter/Recall acknowledgement and return form dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Integra asks customers to review inventory and determine if any of the affected inventory is in possession. The attached Recall Acknowledgement and Return Form should be completed and returned. Customer service will contact the customer upon receipt of the form and provide an RMA number. Questions can be directed to Customer Service at 1-888-301-0203.

Device

Device Recall Integra
  • Modèle / numéro de série
    Model Number FWD301 (US) & FDR301 (Non-US)   The following Lot Numbers on the packaged kits are affected: - 305000293250, 305000293251, 305000298616 (foreign)  The syringes within the packaged kits are also Lot numbered. For the packaged kit Lot Numbers above, the corresponding respective syringe Lot Numbers are:  - 10500028786, 105000288118, 105N00288965 (foreign)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom.
  • Description du dispositif
    Integra¿ Flowable Wound Matrix || Size 3cc 1 unit/box || single use, sterile device Rx Only || Model Number FWD301 (US) & FDR301 (Non-US) || Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: || - An empty plastic syringe with Luer-Lok" tip || - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material || - A syringe-to-syringe Luer-Lok" adapter / connector || - A flexible plastic tube (injector) with Luer-Lok" connector || Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.