Z-2089-2016Class II

IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN...

Name: Z-2089-2016 IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN...
Creator: CMP Industries, Llc
Published: 2016-03-02
License: https://open.fda.gov/license/

Cmp Industries, LLC / initiated 2016-03-02 / Terminated / root cause: manufacturing process

FDA source

CMP Industries, Llc began a recall of 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... on 2016-03-02. FDA classified it as Class II and gives the reason as "Possible presence of foreign material (rust)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2089-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-02
Posted: 2016-06-29
Terminated: 2017-03-16
Recalling firm: Cmp Industries, LLC
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 & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
Product code: EBI Resin, Denture, Relining, Repairing, Rebasing
Reason for recall: Possible presence of foreign material (rust).
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: CMP Industries/Nobilium sent an Urgent IMPAK Recall letter dated March 2, 2016, to all affected customers via certified mail with return receipt in an attempt to verify if customers were in possession of the affected product. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their posession subject to recall, please contact the firm by calling 518-434-3147, ext 144, Monday - Friday 8-4:30 pm, EST.
Quantity in commerce: 236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)
Distribution: Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
Product codes and lots: Lot Number 101113

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2089-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2089-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29

Product code EBI

K033020Class IIImpak Acrylic Repair Resin LiquidCmp Industries, LLC / cleared 2003-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)