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
Z-1313-2025
Product summary
- Firm
- TruAbutment Inc.
- Event
- Event 96246
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-1313-2025
Official wording
Reason: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Code information: Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Distribution pattern: US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
Derived failure modes
-
Unknown
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately