Medical device recalls Moderate risk

TruAbutment Inc. recalls Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38…

Recall date
December 27, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1313-2025
FDA classification
Class II
Brand / firm
TruAbutment Inc.
Sold / distributed
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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