BEUDAMED
    FDA Enforcement Class II Terminated

    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

    Recall: Z-0111-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0111-2022
    Event ID
    88669
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 20, 2021
    Initiation Date
    September 1, 2021
    Classification Date
    October 13, 2021
    Termination Date
    February 16, 2023
    Address
    100 Witmer Rd Ste 280, N/A, Horsham, PA, 19044-2647, United States

    Description

    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

    Reason

    Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

    Code Info

    Lot Number: 2013002721, 2013003589 Unique Identifier: 00840118101264

    Distribution

    Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

    Quantity

    2 units