BEUDAMED
    FDA Recall Terminated

    EXOGEN Ultrasound Coupling Gel

    Recall: Z-0810-2021 · Initiated December 17, 2020

    Recall

    Recall Number
    Z-0810-2021
    Event Number
    87002
    Firm
    Bioventus, LLC
    FEI Number
    3027669735
    Product Code
    LOF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 17, 2020
    Terminated
    August 7, 2024
    Address
    1900 Charles Bryan Rd, Ste 275, Cordova, TN, 38016-5285

    Description

    EXOGEN Ultrasound Coupling Gel

    Reason

    Product may contain white particulates that are microbial in nature.

    Action

    Device Recall Notice 3010203571-12/14/20-001-R was sent to customers beginning 12/17/2020. Customers were instructed to dispose of the product and verify disposal lot and quantity.

    Distribution

    United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

    Quantity

    115,584 units