SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing ...

FDA Device Recall #Z-1208-2023 — Class II — January 20, 2023

Recall Summary

Recall Number Z-1208-2023
Classification Class II — Moderate risk
Date Initiated January 20, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Coltene Whaledent Inc
Location Cuyahoga Falls, OH
Product Type Devices
Quantity 3896 units

Product Description

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 Pattern

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

Lot / Code Information

UDI-DI: +ESANS100010 All Serial Numbers

Other Recalls from Coltene Whaledent Inc

Recall # Classification Product Date
Z-1494-2021 Class II Dental pins - TMS LINK PLUS Self-Threading Pins... Mar 18, 2021
Z-0467-2021 Class II CEI Cutting Edge Instruments (PTC-57C) Oct 20, 2020
Z-0466-2021 Class II Clinic Pack 100 Pieces FG 57 100057C (100057C) Oct 20, 2020
Z-0464-2021 Class II Alpen Clinic 100 Carbide Instruments (R100057C) Oct 20, 2020
Z-0468-2021 Class II Strauss 25 Carbide Dental Burs (100057XXV) Oct 20, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.