Events

Recall of 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
    74061
  • Event Risk Class
    Class 2
  • Event Number
    Z-2097-2016
  • Event Initiated Date
    2016-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146129
  • 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
    On April 28, 2016, Nobilium, Division of CMP Industries LLC distributed Urgent Recall notices and Response Forms to their customers via courier service. 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 possession subject to recall, please contact the firm by calling John Nicpon at 518-434-3147, ext. 144. Hours of operation are Monday - Friday 8-4:30 pm, EST. Return completed recall response forms to nicpon@nobilium.com.

Device

IMPAK Liquid Acrylic Resin
  • Model / Serial
    Lot Number: 79943 Expiration Date: March 2021
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
  • Product Description
    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
  • 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