BEUDAMED
    FDA Recall Terminated

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    Recall: Z-0034-2022 · Initiated September 3, 2021

    Recall

    Recall Number
    Z-0034-2022
    Event Number
    88724
    Firm
    Flower Orthopedics Corporation
    FEI Number
    3009996260
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 3, 2021
    Terminated
    July 28, 2022
    Address
    100 Witmer Rd, Ste 280, Horsham, PA, 19044-2647

    Description

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    Reason

    Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

    Action

    Coventus Flower Orthopedics issued letter dated 9/3/21 via email. Letter states reason fo recall, health risk and action to take: Check your inventory for the product listed below. Look into the see-through window in the box and determine if a CDG 200 is included. The CDG 200 resembles a pen and has a long, black handle and a silver tip. A photo of the CDG 200 is 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 an EWK 201 that is missing the CDG 200 component, Conventus Flower will ask that you return that affected kit. Conventus Flower will then send a replacement EWK 201 kit. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.

    Quantity

    77 kits