BEUDAMED
    FDA Enforcement Class II Terminated

    OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    Recall: Z-0866-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0866-2021
    Event ID
    85133
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skeletal Kinetics, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2021
    Initiation Date
    June 6, 2019
    Classification Date
    January 15, 2021
    Termination Date
    September 18, 2024
    Address
    3885 Arapaho Rd, N/A, Addison, TX, 75001-4314, United States

    Description

    OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    Reason

    A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.

    Code Info

    OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957

    Distribution

    U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.

    Quantity

    2 units