Class II — TruAbutment Inc.
| Recalling firm | TruAbutment Inc. |
|---|---|
| Registered facility | TRUABUTMENT INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately |
| 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 |
| Quantity | 61 units |
| Distribution | US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada |
| Initiated | 2023-12-27 |
| Classified | 2025-03-11 |
| Recall number | Z-1313-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TruAbutment Inc. (Z-1313-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96246/
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