Home / Recalls / Coltene Whaledent Inc / Z-1208-2023

Z-1208-2023 Class II Ongoing

Recalled by Coltene Whaledent Inc — Cuyahoga Falls, OH

Recall Details

Product Type
Devices
Report Date
March 8, 2023
Initiation Date
January 20, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product 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

Code Information

UDI-DI: +ESANS100010 All Serial Numbers

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