FDA Medical Device Recalls (openFDA)
CMP Industries, Llc: 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.
- Recall number
- Z-1089-2016
- 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.
- Status
- Terminated
- Initiated
- 2013-11-18
- Posted
- 2016-03-09
- Terminated
- 2018-05-23
- Reason
- 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
- 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
- 246 units
- Distribution
- Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
- Lot, serial or model codes
- Lot Number 103113
- 510(k) numbers
- ["K033020"]
- PMA numbers
- not on file
- Product code
- EBI
- Firm FEI
- 1315551
- Firm city
- Albany
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28