CMP Industries, Llc: Medical Device Recall in 2016 - (Recall #: Z-2097-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.

Product Classification:

Class II

Date Initiated: April 28, 2016

Date Posted: July 6, 2016

Recall Number: Z-2097-2016

Event ID: 74061

Reason for Recall:

Possible presence of foreign material (rust).

Status: Terminated

Product Quantity: 77 units Total

Code Information:

Lot Number: 79943 Expiration Date: March 2021

Distribution Pattern:

Domestic - MI, MN, NJ, NM, NY & PA; International - Canada

Voluntary or Mandated:

Voluntary: Firm initiated