BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1313-2025 · Initiated December 27, 2023

    Recall

    Recall Number
    Z-1313-2025
    Event Number
    96246
    Firm
    TruAbutment Inc.
    FEI Number
    3012422693
    Product Code
    NDP
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    December 27, 2023
    Posted
    March 11, 2025
    Address
    17666 Fitch, Irvine, CA, 92614-6022

    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

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

    Action

    On February 3, 2025, TruAbutment Inc. begin to reach out to affected customers about the recall. On February 13, 2025, TruAbutment Inc. followed up with consignees by phone and followed up the phone call with a "Urgent: Medical Device Recall" Notification. TruAbutment asked consignees to take the following actions: 1. Stop usage and quarantine all CN38-SB until your on-hand products are verified. 2. Check all unopened CN38-SB. a. Please check the Lot # and quarantine the products with Lot # KCCBB1216110. 3. Then check the opened CN38-SB products. 4. Please quarantine any unaligned products. 4. Please return the quarantined products back to TruAbutment with the signed acknowledgement and replacement form that is attached to this letter. 5.If the product was transferred or distributed to a different facility, please forward this notification and inform TruAbutment Inc. by contacting the customer support team with the information below.

    Distribution

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

    Quantity

    61 units