Z-1313-2025 Class II Ongoing

Recalled by TruAbutment Inc. — Irvine, CA

Recall Details

Product Type
Devices
Report Date
March 19, 2025
Initiation Date
December 27, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
61 units

Product Description

Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

Reason for Recall

Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

Distribution Pattern

US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada

Code Information

Lot Code: KCCBB1216110/ UDI: (01)08800076411791