Recall Z-1313-2025— TruAbutment Inc.
Class II · Ongoing
Class II FDA medical device recall by TruAbutment Inc., initiated 2023-12-27. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately.
- Recalling firm
- TruAbutment Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-27
- Firm location
- Irvine, CA, United States
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
Reason for recall
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Data sourced from openFDA. This site is unofficial and independent of the FDA.