Events

Recall of Device Recall IMPAK Liquid Acrylic Resin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CMP Industries, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73629
  • Event Risk Class
    Class 2
  • Event Number
    Z-2089-2016
  • Event Initiated Date
    2016-03-02
  • Event Date Posted
    2016-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144626
  • Notes / Alerts
    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.
  • Extra notes in the data
    Resin, denture, relining, repairing, rebasing - Product Code EBI
  • Reason
    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
  • Model / Serial
    Lot Number 101113
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
  • Product Description
    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
  • Manufacturer Address
    CMP Industries, Llc, 413 N Pearl St, Albany NY 12207-1311
  • Manufacturer Parent Company (2017)
    CMP Industries, Llc
  • Source
    USFDA