# FDA recall Z-1100-2022

> **Clinician's Choice Dental Products Inc.** · Class II · device recall initiated 2022-03-18.

## 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

## Distribution

Distributed in SC.

## Key facts

- **Recall number:** Z-1100-2022
- **Recalling firm:** Clinician's Choice Dental Products Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-18
- **Report date:** 2022-05-25
- **Termination date:** 2024-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brookfield, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2022

## Citation

> AI Analytics. FDA recall Z-1100-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1100-2022. Source: US FDA. Licensed CC0.

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