Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 M...
FDA Recall #Z-1313-2025 — Class II — December 27, 2023
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
Recalling Firm
TruAbutment Inc. — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
61 units
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated