BEUDAMED
    FDA Enforcement Class II Ongoing

    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S

    Recall: Z-0074-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0074-2024
    Event ID
    93024
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 18, 2023
    Initiation Date
    August 29, 2023
    Classification Date
    October 6, 2023
    Address
    100 Witmer Rd Ste 280, N/A, Horsham, PA, 19044-2647, United States

    Description

    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S

    Reason

    Device is breaking while in use, potential for patients to require a revision surgery.

    Code Info

    UDI:00840118117432 Lot Number: 2304323076

    Distribution

    US Nationwide distribution.

    Quantity

    70 units