BEUDAMED
    FDA Enforcement Class II Ongoing

    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

    Recall: Z-0101-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0101-2023
    Event ID
    90918
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 27, 2022
    Classification Date
    October 18, 2022
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

    Reason

    The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

    Code Info

    UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027

    Distribution

    US Nationwide distribution.

    Quantity

    196