Recall archive / FDA device enforcement
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN... — FDA record Z-1313-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
- Classification
- Class II
- Recalling firm
- TruAbutment Inc.
- Quantity
- 61 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1313-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: KCCBB1216110/ UDI: (01)08800076411791 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 19, 2025
- Recall initiation date
- Dec 27, 2023
- Center classification date
- Mar 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.