Z-1208-2023 Class II Ongoing
FDA device recall Z-1208-2023 was initiated by Coltene Whaledent Inc on Jan 20, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 3896 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 8, 2023
- Initiation Date
- Jan 20, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1208-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026