Z-1494-2022 Class II Ongoing
FDA device recall Z-1494-2022 was initiated by Dental Choice Holding Llc on May 23, 2022 and is designated Class II. Reason for recall: The device was marketed and sold in the US without FDA clearance. The recall status is ongoing. Affected quantity: 708.
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2022
- Initiation Date
- May 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 708
Product Description
CustMbite, Model Number CBT-SRS-UL
Reason for Recall
The device was marketed and sold in the US without FDA clearance.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222