# FDA recall Z-1168-2024

> **W&H DENTALWERK BUERMOOS GMBH** · Class II · device recall initiated 2024-01-16.

## Product

W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue  Model Number: 30061000

## Reason for recall

1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada,  Australia, Philippines, Sweden.

## Key facts

- **Recall number:** Z-1168-2024
- **Recalling firm:** W&H DENTALWERK BUERMOOS GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-16
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** BUERMOOS, N/A, Austria

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2024

## Citation

> AI Analytics. FDA recall Z-1168-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1168-2024. Source: US FDA. Licensed CC0.

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