BEUDAMED
    FDA Recall Open, Classified

    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

    Recall: Z-0955-2025 · Initiated November 27, 2024

    Recall

    Recall Number
    Z-0955-2025
    Event Number
    95981
    Firm
    IsoTis OrthoBiologics, Inc.
    FEI Number
    3001503333
    Product Code
    MQV
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    November 27, 2024
    Posted
    January 16, 2025
    Address
    2 Goodyear, Ste A, Irvine, CA, 92618-2052

    Description

    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

    Reason

    Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

    Action

    An Urgent Medical Device Recall notice was issued via email 11/27/2024. The notice advised consignees to either use the product by the expiration date listed in the notice or return the affected part(s) using provided shipping label and complete and return the Acknowledgement and Receipt Form as soon as possible. Direct questions regarding this matter to Danielle Becker at [email protected] or Danielle Nelson-Archer at [email protected].

    Distribution

    US Nationwide distribution in the states of IN, TN & TX.

    Quantity

    22