FDA recall Z-1313-2025

TruAbutment Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2023-12-27
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2025