FDA recall Z-1208-2023

Coltene Whaledent Inc · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1208-2023