Z-1089-2016Class II

IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11...

Name: Z-1089-2016 IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11...
Creator: CMP Industries, Llc
Published: 2013-11-18
License: https://open.fda.gov/license/

Cmp Industries, LLC / initiated 2013-11-18 / Terminated / root cause: manufacturing process

FDA source

CMP Industries, Llc began a recall of IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for... on 2013-11-18. FDA classified it as Class II and gives the reason as "During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district". 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-1089-2016
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Posted: 2016-03-09
Terminated: 2018-05-23
Recalling firm: Cmp Industries, LLC
Product: IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
Product code: EBI Resin, Denture, Relining, Repairing, Rebasing
Reason for recall: During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On November 18, 2013, CMP Customer Service contacted customers by telephone requesting return of the affected product and customers were issued a UPS Call Tag. CMP issued a letter to non-responding customers dated December 9, 2013, requesting return of the product because of the possibility of foreign particles. The letter states, the firm found that one of their processes could deliver a material that would pass their QC tests, but may introduce foreign material into the liquid. A customer service representative will be in contact with customers to arrange the return of the product.
Quantity in commerce: 246 units
Distribution: Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
Product codes and lots: Lot Number 103113

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-09

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)