Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK-… — Class II medical device recall Z-1100-2022
Terminated recall by Clinician's Choice Dental Products Inc., reported 2022-05-25. Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body visco
| Recall number | Z-1100-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinician's Choice Dental Products Inc., Brookfield, CT, United States |
| Recall initiated | 2022-03-18 |
| Classified | 2022-05-17 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2024-03-19 |
| Quantity | 46 units |
| UPC / GTIN / UDI-DI | 07540172000178 |
| Lot numbers | 611612 |
Product
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Reason for recall
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
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-1100-2022. 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.