Events

Rappel de Device Recall IMPAK Liquid Acrylic Resin

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 CMP Industries, Llc.

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
    73629
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2089-2016
  • Date de mise en oeuvre de l'événement
    2016-03-02
  • Date de publication de l'événement
    2016-06-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144626
  • 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
    Resin, denture, relining, repairing, rebasing - Product Code EBI
  • Cause
    Possible presence of foreign material (rust).
  • Action
    CMP Industries/Nobilium sent an Urgent IMPAK Recall letter dated March 2, 2016, to all affected customers via certified mail with return receipt in an attempt to verify if customers were in possession of the affected product. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their posession subject to recall, please contact the firm by calling 518-434-3147, ext 144, Monday - Friday 8-4:30 pm, EST.

Device

Device Recall IMPAK Liquid Acrylic Resin
  • Modèle / numéro de série
    Lot Number 101113
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
  • Description du dispositif
    IMPAK Liquid Acrylic Resin sold under the following labels: || 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 || 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 || 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 || 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, || 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 || Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
  • Manufacturer
    CMP Industries, Llc

Manufacturer

CMP Industries, Llc
  • Adresse du fabricant
    CMP Industries, Llc, 413 N Pearl St, Albany NY 12207-1311
  • Société-mère du fabricant (2017)
    CMP Industries, Llc
  • Source
    USFDA