Events

Rappel de Device Recall SalineFilled SPECTRUM Breast Implants

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 Mentor Texas, LP..

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
    76868
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2070-2017
  • Date de mise en oeuvre de l'événement
    2017-03-27
  • Date de publication de l'événement
    2017-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154428
  • 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
    Prosthesis, breast, inflatable, internal, saline - Product Code FWM
  • Cause
    Missing dome pack accessory.
  • Action
    Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Actions Requested If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action. Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed. If you have sent these units to another facility, forward this notice to that facility. Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. We apologize for any inconvenience this may cause. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. If you have any questions related to this notice, please contact your local Mentor Sales Representative or Mentor Customer Service at 1-800-235-5731. For further questions please call (972) 252-6060. Thank you for your attention and cooperation.

Device

Device Recall SalineFilled SPECTRUM Breast Implants
  • Modèle / numéro de série
    Lot Number: 7377332
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
  • Description du dispositif
    Mentor Smooth Round SPECTRUM Post- || Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
  • Manufacturer
    Mentor Texas, LP.

Manufacturer

Mentor Texas, LP.
  • Adresse du fabricant
    Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA