BEUDAMED
    FDA Enforcement Class II Ongoing

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    Recall: Z-1718-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1718-2025
    Event ID
    96632
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SCIENCE & BIO MATERIALS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 14, 2025
    Initiation Date
    April 7, 2025
    Classification Date
    May 2, 2025
    Address
    Zi Du Monge, N/A, Lourdes, N/A, N/A, France

    Description

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    Reason

    Vials of implant bone granules may contain less product then specified on labeling.

    Code Info

    Lot # 240781/UDI: 03760154000369

    Distribution

    US Nationwide distribution.

    Quantity

    30 vials