Home / Recalls / Medical Devices
Coltene Whaledent Inc recalls SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c
Recalled March 8, 2023 · FDA recall Z-1208-2023 · Coltene Whaledent
Hazard
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 · FDA Class II
Units
3896 units
Sold at
Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
Description
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
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
Manufacturer(s)
Coltene Whaledent Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →