BEUDAMED
    FDA Recall Terminated

    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any 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: DBK 027

    Recall: Z-0113-2022 · Initiated September 1, 2021

    Recall

    Recall Number
    Z-0113-2022
    Event Number
    88669
    Firm
    Flower Orthopedics Corporation
    FEI Number
    3009996260
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    September 1, 2021
    Terminated
    February 16, 2023
    Address
    100 Witmer Rd, Ste 280, Horsham, PA, 19044-2647

    Description

    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any 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: DBK 027

    Reason

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

    Action

    Coventus Orthopedic issued email communication on 9/01/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below. Next, please complete and return the attached Acknowledgement and Receipt Form by Friday, September 10, 2021. If you indicate on the form that you are in possession of affected product, Conventus Flower will ask that you return that affected kits. Conventus Flower will send replacement product as soon as we receive your completed Acknowledgement and Receipt Form. New DBK 020, DBK 024, DBK 027, or LSK 027 kits will be shipped to customers to replace affected product once the Acknowledgement and Receipt Form is received. Other Information: "Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]

    Distribution

    Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

    Quantity

    3 units