Brand Name: TruScan Body — Class II medical device recall Z-1313-2025
Ongoing recall by TruAbutment Inc., reported 2025-03-19, distributed in CA, CO, FL, GA, IA, IL, MD, MN…. Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
| Recall number | Z-1313-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TruAbutment Inc., Irvine, CA, United States |
| Recall initiated | 2023-12-27 |
| Classified | 2025-03-11 |
| Reported by FDA | 2025-03-19 |
| Distributed | CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI |
| Countries outside the US | CA, GB, JP |
| Quantity | 61 units |
| UPC / GTIN / UDI-DI | 08800076411791 |
| Lot numbers | KCCBB1216110 |
| Model numbers | CN38-SB |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1313-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.