# FDA recall Z-2421-2020

> **Coltene Whaledent Inc** · Class II · device recall initiated 2020-06-03.

## Product

HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

## Reason for recall

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

## Distribution

Pending

## Key facts

- **Recall number:** Z-2421-2020
- **Recalling firm:** Coltene Whaledent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-03
- **Report date:** 2020-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cuyahoga Falls, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2421-2020

## Citation

> AI Analytics. FDA recall Z-2421-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2421-2020. Source: US FDA. Licensed CC0.

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