BEUDAMED
    FDA Recall Open, Classified

    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4

    Recall: Z-2393-2023 · Initiated June 23, 2023

    Recall

    Recall Number
    Z-2393-2023
    Event Number
    92689
    Firm
    Cytrellis Biosystems, Inc.
    FEI Number
    3020704367
    Product Code
    QAI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 23, 2023
    Posted
    August 11, 2023
    Address
    299 Washington St, Ste C, Woburn, MA, 01801-2793

    Description

    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4

    Reason

    Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring

    Action

    Cytrellis Biosystems, Inc issued Urgent Medical Device Recall letter via email on 6/23/23 and revised letter on 7/7/23. Letter states reason for recall, health risk and action to take: A member of our service engineering team will be reaching out to your practice to schedule a visit to conduct the software update to your console on site. The visit will take approximately 30-45 minutes. Our goal for the completion of updates for all existing customers is by August 31st. Actions to be taken by the Customer: 1) If you drop or have dropped your handpiece, stop immediate use of the handpiece and contact Cytrellis. 2) Complete the attached Recall Return Response Form and provide it to the service engineering representative that conducts the software update on the device located at your site as acknowledgment of this recall. Any questions can be directed to [email protected]. Website: www.cytrellis.com

    Distribution

    Nationwide

    Quantity

    127 systems