BEUDAMED
    FDA Enforcement Class II Terminated

    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

    Recall: Z-0638-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0638-2021
    Event ID
    86755
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocomposites, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    December 30, 2020
    Initiation Date
    November 12, 2020
    Classification Date
    December 18, 2020
    Termination Date
    April 27, 2021
    Address
    Keele Science Park, N/A, Keele Staffordshire, N/A, N/A, United Kingdom

    Description

    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

    Reason

    The product is mislabeled.

    Code Info

    Lot SK190610, Expiry June 2022

    Distribution

    Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.

    Quantity

    54 boxes