# FDA recall Z-1883-2018

> **Coltene Whaledent Inc** · Class II · device recall initiated 2018-04-13.

## Product

Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.

## Reason for recall

The products are labeled with an incorrect product number.

## Distribution

The products were distributed to the following US states: NY.    The products were distributed to the following foreign countries: Canada

## Key facts

- **Recall number:** Z-1883-2018
- **Recalling firm:** Coltene Whaledent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2018-05-23
- **Termination date:** 2019-04-08

- **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-1883-2018

## Citation

> AI Analytics. FDA recall Z-1883-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1883-2018. Source: US FDA. Licensed CC0.

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