Recall Z-1208-2023— Coltene Whaledent Inc

Name: FDA recall Z-1208-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-20

Class II · Ongoing

Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2023-01-20. It names one FDA 510(k) clearance: K071891. 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: 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.

Recalling firm: Coltene Whaledent Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-01-20
Firm location: Cuyahoga Falls, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K071891 — STATIS DENTAL HANDPIECESScican , Ltd.·cleared 2007-09-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.