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Recall Observatory FDA recall evidence

Device 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

Z-1313-2025

December 27, 2023

Class II

Product summary

Firm
TruAbutment Inc.
Event
Event 96246
Status
Ongoing
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-1313-2025

Official wording

Reason: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

Code information: Lot Code: KCCBB1216110/ UDI: (01)08800076411791

Distribution pattern: US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately