BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0034-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0034-2022
    Event ID
    88724
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 13, 2021
    Initiation Date
    September 3, 2021
    Classification Date
    October 6, 2021
    Termination Date
    July 28, 2022
    Address
    100 Witmer Rd Ste 280, Horsham, PA, 19044-2647, United States

    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)

    Code Info

    Lot Number: 2104321637 Unique Identifier: 00840118112079

    Distribution

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

    Quantity

    77 kits