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
    71148
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1089-2016
  • Date de mise en oeuvre de l'événement
    2013-11-18
  • Date de publication de l'événement
    2016-03-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136262
  • 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
    During the current inspection of cmp industries, the fda investigator discovered that the firm had conducted a recall of impak acrylic liquid batch 103113 in 2013 due to potential rust without notifying the district.
  • Action
    On November 18, 2013, CMP Customer Service contacted customers by telephone requesting return of the affected product and customers were issued a UPS Call Tag. CMP issued a letter to non-responding customers dated December 9, 2013, requesting return of the product because of the possibility of foreign particles. The letter states, the firm found that one of their processes could deliver a material that would pass their QC tests, but may introduce foreign material into the liquid. A customer service representative will be in contact with customers to arrange the return of the product.

Device

Device Recall IMPAK Liquid Acrylic Resin
  • Modèle / numéro de série
    Lot Number 103113
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
  • Description du dispositif
    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. || Indicated for relining a denture surface 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