TruScan Body dental scanner recalled due to scanning malfunction
TruAbutment Inc. recalls 61 units of the TruScan Body dental scanner (CN38-SB) due to defects that may prevent proper or accurate scanning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with defects that prevent proper function. The device may not scan accurately, creating a risk of harm in dental implant planning. No injuries or illnesses have been reported.
Plain-English summary
TruAbutment Inc. is recalling 61 units of the TruScan Body dental scanner, model CN38-SB. The device is designed to scan dental implant sites and is compatible with CONELOG 3.8 implants.
The FDA identified defects and quality issues in the device that may cause it to scan improperly or inaccurately. A dental scanner that does not function correctly or produces inaccurate scans could affect the quality of implant planning and clinical outcomes.
The affected units were distributed in the United States to dental providers in California, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Minnesota, Mississippi, Ohio, Oregon, South Dakota, Utah, Virginia, Washington, and Wisconsin. Units were also distributed internationally to Japan, Great Britain, and Canada. The lot number is KCCBB1216110.
Dental professionals using this device should contact TruAbutment Inc. for recall instructions and guidance.
The recalled product
- 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
- Manufacturer
- TruAbutment Inc.
- Category
- Medical Device — Dental Scanner
- Affected units
- 61
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Distribution
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