BEUDAMED
    FDA Enforcement Class II Terminated

    Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1

    Recall: Z-0448-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0448-2022
    Event ID
    89092
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 2, 2021
    Classification Date
    January 3, 2022
    Termination Date
    October 12, 2023
    Address
    100 Witmer Rd Ste 280, N/A, Horsham, PA, 19044-2647, United States

    Description

    Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1

    Reason

    Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available

    Code Info

    Lot Number: 11090 UDI: 00840118117548

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.

    Quantity

    48 units