BEUDAMED
    FDA Enforcement Class II Completed

    Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4

    Recall: Z-1648-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1648-2023
    Event ID
    92187
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Cytrellis Biosystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 7, 2023
    Initiation Date
    April 7, 2023
    Classification Date
    May 26, 2023
    Address
    299 Washington St Ste C, N/A, Woburn, MA, 01801-2793, United States

    Description

    Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4

    Reason

    Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.

    Code Info

    UDI-DI: B933ELCON010 All serial numbers

    Distribution

    Nationwide

    Quantity

    89 units