Brand Name: TruScan Body, REF CN38-SB recallZ-1313-2025 · TruAbutment Inc. · initiated Dec 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TruAbutment Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
On February 3, 2025, TruAbutment Inc. begin to reach out to affected customers about the recall. On February 13, 2025, TruAbutment Inc. followed up with consignees by phone and followed up the phone call with a "Urgent: Medical Device Recall" Notification. TruAbutment asked consignees to take the following actions: 1. Stop usage and quarantine all CN38-SB until your on-hand products are verified. 2. Check all unopened CN38-SB. a. Please check the Lot # and quarantine the products with Lot # KCCBB1216110. 3. Then check the opened CN38-SB products. 4. Please quarantine any unaligned products. 4. Please return the quarantined products back to TruAbutment with the signed acknowledgement and replacement form that is attached to this letter. 5.If the product was transferred or distributed to a different facility, please forward this notification and inform TruAbutment Inc. by contacting the customer support team with the information below.
Recall details
- Recall number
- Z-1313-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 27, 2023
- Posted by the FDA
- Mar 11, 2025
- Recalling firm
- TruAbutment Inc.
- Quantity
- 61 units
- Product code
- NDP
- Distribution
- US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
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
Code information (models, lots, serial numbers)
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TruScan Body CN38-SBTruabutment Korea Co.,Ltd · Accessories, Implant, Dental, Endosseous1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page