The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2098-2016·Announced 2016-07-06

CMP Industries Recalls Impak Elastic Acrylic Resin Due to Rust

CMP Industries is recalling Impak Elastic Acrylic Resin Powder and Liquid due to the possible presence of foreign material, specifically rust.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (foreign material/rust) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products without reported illness.

Plain-English summary

CMP Industries, LLC is recalling 77 units of Impak Elastic Acrylic Resin Powder & Liquid, Shade Transparent, Reference 3746. The product is indicated for relining a denture surface and is available by prescription only. The recall is due to the possible presence of foreign material, specifically rust.

The affected product is Lot Number 79943 with an expiration date of March 2021. The distribution pattern includes domestic locations in Michigan, Minnesota, New Jersey, New Mexico, New York, and Pennsylvania, as well as international distribution to Canada.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
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
Category
Medical Device — Dental Materials
Hazard
Affected units
77

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: 79943 Expiration Date: March 2021

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by CMP Industries, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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