IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK… — Class II medical device recall Z-2097-2016
Terminated recall by CMP Industries, Llc, reported 2016-07-06, distributed in MI, MN, NJ, NM, NY, PA. Possible presence of foreign material (rust).
| Recall number | Z-2097-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CMP Industries, Llc, Albany, NY, United States |
| Recall initiated | 2016-04-28 |
| Classified | 2016-06-29 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-05-25 |
| Distributed | MI, MN, NJ, NM, NY, PA |
| Countries outside the US | CA |
| Quantity | 77 units |
| Reason classes | foreign material |
| Lot numbers | 79943 |
| Model numbers | 3306, 3748 |
| Expiration dates | 2021-03-20 |
Product
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.
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-2097-2016. 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.