IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK… — Class II medical device recall Z-2089-2016
Terminated recall by CMP Industries, Llc, reported 2016-07-06, distributed in CA, IN, LA, MI, NY, OH, WA. Possible presence of foreign material (rust).
| Recall number | Z-2089-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CMP Industries, Llc, Albany, NY, United States |
| Recall initiated | 2016-03-02 |
| Classified | 2016-06-29 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-03-16 |
| Distributed | CA, IN, LA, MI, NY, OH, WA |
| Reason classes | foreign material |
| Lot numbers | 101113 |
| Model numbers | 3314, 3748 |
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
Reason for recall
Possible presence of foreign material (rust).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2089-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.