Z-1313-2025Class II

Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog...

Name: Z-1313-2025 Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog...
Creator: TruAbutment Inc.
Published: 2023-12-27
License: https://open.fda.gov/license/

TruAbutment Inc. / initiated 2023-12-27 / Open, Classified

FDA source

TruAbutment Inc. began a recall of 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 on 2023-12-27. FDA classified it as Class II and gives the reason as "Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1313-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-27
Posted: 2025-03-11
Recalling firm: TruAbutment Inc.
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
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
FDA root cause: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 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
Product codes and lots: Lot Code: KCCBB1216110/ UDI: (01)08800076411791

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1313-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1313-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)