Z-1313-2025 Class II Ongoing
FDA device recall Z-1313-2025 was initiated by TruAbutment Inc. on Dec 27, 2023 and is designated Class II. Reason for recall: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately The recall status is ongoing. Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 19, 2025
- Initiation Date
- Dec 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product Description
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 Pattern
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
Code Information
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1313-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026