Class II

Medical Device Recall: 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

TruAbutment Inc. · December 27, 2023

Reason for Recall

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

Distribution

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

States Affected

CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI

Quantity Affected

61 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1313-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.