# FDA recall Z-1208-2023

> **Coltene Whaledent Inc** · Class II · device recall initiated 2023-01-20.

## Product

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth.  Model Number: S10001

## Reason for recall

Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

## Distribution

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

## Key facts

- **Recall number:** Z-1208-2023
- **Recalling firm:** Coltene Whaledent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-20
- **Report date:** 2023-03-08

- **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-1208-2023

## Citation

> AI Analytics. FDA recall Z-1208-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1208-2023. Source: US FDA. Licensed CC0.

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