TruScan Body (TruAbutment) – scanning accuracy problems (2023)
Dental scanner may have quality issues affecting scanning accuracy.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
TruAbutment Inc.
Lot Codes / Batch Numbers
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Products Sold
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
TruAbutment Inc. is recalling Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Mode due to Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, GA, IL, IA, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI
Page updated: Jan 10, 2026