# FDA recall Z-0465-2021

> **Coltene Whaledent Inc** · Class II · device recall initiated 2020-10-20.

## Product

FG 57 100057X (100057X)

## Reason for recall

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

## Distribution

Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-0465-2021
- **Recalling firm:** Coltene Whaledent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-10-20
- **Report date:** 2020-11-25

- **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-0465-2021

## Citation

> AI Analytics. FDA recall Z-0465-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0465-2021. Source: US FDA. Licensed CC0.

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