FDA Device recall Z-1313-2025
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version…
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version… by Truabutment, citing retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1313-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-27 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Truabutment |
| Distribution | CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI |
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
Identifiers
| code_info | Lot Code: KCCBB1216110/ UDI: (01)08800076411791 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1313-2025%22
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