FDA Medical devices recall ·
TruScan Body recall
- Recall number
- Z-1313-2025
- Date
- (initiated December 27, 2023)
- Company / brand
- TruAbutment Inc.
17666 Fitch, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 61 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Distribution
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
States: California Colorado Florida Georgia Iowa Illinois Maryland Minnesota Mississippi Ohio Oregon South Dakota Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1313-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.