Irvine, CA, United States
TruAbutment Inc. recalls
1 recall recorded since 2018, most recently on 27 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 December 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1313-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.