BEUDAMED
    FDA Recall 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 · Initiated November 2, 2021

    Recall

    Recall Number
    Z-0448-2022
    Event Number
    89092
    Firm
    Flower Orthopedics Corporation
    FEI Number
    3009996260
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 2, 2021
    Terminated
    October 12, 2023
    Address
    100 Witmer Rd, Ste 280, Horsham, PA, 19044-2647

    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

    Action

    Conventus Flower Orthopedics issued Urgent Recall Information letter dated 11/2/21 stating reason for recall, health risk and action to take: Check your inventory for the product listed below and immediately replace with the new product provided. 2.Next, please complete and return the attached Acknowledgement and ReceiptForm with the affected product in the provided packaging by November 5, 2021. 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, GA, TN, FL, IL, MA, MD, NC, TX.

    Quantity

    48 units