---
title: "Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl... — FDA record Z-1100-2022 | Is It on Recall"
description: "Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12"
url: https://isitonrecall.com/recall/fda-device-z-1100-2022-affinity-hydroactive-impression-material-heavy-body-regular-set-12pk-a-vinyl-poly-siloxane-material/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, ... — FDA record Z-1100-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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
- **Classification**: Class II
- **Recalling firm**: Clinician's Choice Dental Products Inc.
- **Quantity**: 46 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1100-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1100-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | LOT No.: 611612 (UDI): 07540172000178 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distributed in SC.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [South Carolina](https://isitonrecall.com/state/south-carolina/)

## Dates in the source

- **Report date**: May 25, 2022
- **Recall initiation date**: Mar 18, 2022
- **Center classification date**: May 17, 2022
- **Termination date**: Mar 19, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1100-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Clinician's Choice Dental Products Inc. records](https://isitonrecall.com/brand/clinician-s-choice-dental-products-inc/)
