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
    71148
  • Event Risk Class
    Class 2
  • Event Number
    Z-1089-2016
  • Event Initiated Date
    2013-11-18
  • Event Date Posted
    2016-03-09
  • 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=136262
  • 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
    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
  • Model / Serial
    Lot Number 103113
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
  • Product Description
    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
  • Manufacturer Address
    CMP Industries, Llc, 413 N Pearl St, Albany NY 12207-1311
  • Manufacturer Parent Company (2017)
    CMP Industries, Llc
  • Source
    USFDA