The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0292-2019·Announced 2018-11-07

CMP Industries Recalls Dental Resin Liquid Due to Foreign Material

CMP Industries is recalling specific lots of Impak Elastic Acrylic Resin Liquid because foreign material was found in the product.

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 foreign material hazard where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

CMP Industries, LLC is recalling 400 units of Impak Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml), REF:3306. The product is used for dental splints and dental nightguards. The recall is due to the presence of foreign material in the product.

The affected lots are 85623 and 85827. The product was distributed worldwide, including nationwide in the United States in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, and WA, as well as in Canada and Spain.

Consumers and dental professionals should stop using the affected product and contact CMP Industries, LLC for further instructions or a refund.

The recalled product

Product
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Manufacturer
CMP Industries, Llc
Category
Medical Device — Dental Materials
Hazard
Affected units
400

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 (2)

  • Lot Number: 85623
  • 85827

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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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