Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN
Summary
The FDA issued a Class II for Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible wi by TruAbutment Inc.. Reason: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately.
Details
Source
Device Recall
External ID
Z-1313-2025
Action Date
2025-03-19
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Quantity Affected: 61 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-27
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 159 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TruAbutment Inc. has 8 FDA actions in our database, including 1 recall and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TruAbutment Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TruAbutment Inc. have FDA actions?
TruAbutment Inc. has 8 FDA actions in our database, including 1 recall and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1313-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29