BEUDAMED
    FDA Enforcement Class II Terminated

    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

    Recall: Z-0114-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0114-2022
    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 Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

    Reason

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

    Code Info

    Lot Number: 2013003419 Unique Identifier: 00840118103688

    Distribution

    Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

    Quantity

    1 unit