# FDA recall Z-1313-2025

> **TruAbutment Inc.** · Class II · device recall initiated 2023-12-27.

## 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

## Distribution

US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI  OUS:  Japan, Great Britain , Canada

## Key facts

- **Recall number:** Z-1313-2025
- **Recalling firm:** TruAbutment Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-27
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2025

## Citation

> AI Analytics. FDA recall Z-1313-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1313-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*