CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
TruScan Body recalled by TruAbutment
TruAbutment is recalling TruScan Body, distributed in 16 states. The recall was initiated on 27 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1313-2025
- FDA event ID
- 96246
- Recalling firm
- TruAbutment, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Dec 2023
- FDA classified
- 11 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 27 Dec 2023 | Recall initiated by company | |
| 11 Mar 2025 | Classified by FDA | +440 days |
| 19 Mar 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
CaliforniaColoradoFloridaGeorgiaIowaIllinoisMarylandMinnesotaMississippiOhioOregonSouth DakotaUtahVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Which lots are affected?
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Where was it sold?
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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