The Recall Desk
ModerateFDA (Devices)·Z-2089-2016·Announced 2016-07-06

CMP Industries Recalls IMPAK Liquid Acrylic Resin Due to Rust

CMP Industries is recalling specific lots of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected products are used for dental applications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is the possible presence of foreign material (rust) in a dental resin, which is a low-risk contamination issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

CMP Industries, LLC is recalling specific lots of IMPAK Liquid Acrylic Resin products. The recall is due to the possible presence of foreign material, specifically rust, in the product. The affected items include IMPAK PF Pink-Fibered Elastic Acrylic Resin Liquid, IMPAK Elastic Acrylic Resin Liquid, IMPAK Elastic Acrylic Resin Liquid for Mouthguards & Bruxism Splints, BRUX-EZE Elastic Acrylic Resin, and ThermoFlex Elastic Acrylic Resin Liquid. These products are indicated for relining denture surfaces, repairing fractured dentures, or forming new denture bases.

The recall involves Lot Number 101113. A total of 236 pieces were distributed, consisting of 25 pieces of the 11-ounce size and 211 pieces of the 1-quart size. Distribution was worldwide, including the United States (specifically California, Michigan, Louisiana, Ohio, New York, Indiana, and Washington) and internationally to Canada.

Consumers and dental professionals who have purchased or received these specific lots should stop using the product and contact CMP Industries for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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 &

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number 101113

Distribution

Distributed in 7 states: