BEUDAMED
    FDA Enforcement Class II Terminated

    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300

    Recall: Z-1698-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1698-2021
    Event ID
    87906
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    April 15, 2021
    Classification Date
    June 1, 2021
    Termination Date
    November 12, 2021
    Address
    100 Witmer Rd Ste 280, Horsham, PA, 19044-2647, United States

    Description

    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300

    Reason

    Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages

    Code Info

    Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853

    Distribution

    US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.

    Quantity

    47 units