Coltene Whaledent Inc recalls SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure,…

Recall date

January 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1208-2023

FDA classification

Class II

Brand / firm

Coltene Whaledent Inc

Sold / distributed

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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