BEUDAMED
    FDA Enforcement Class II Ongoing

    Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

    Recall: Z-0008-2023 · Reported October 12, 2022

    Enforcement

    Recall Number
    Z-0008-2023
    Event ID
    90842
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2022
    Initiation Date
    August 30, 2022
    Classification Date
    October 6, 2022
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

    Reason

    Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

    Code Info

    UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027

    Distribution

    US Nationwide distribution.

    Quantity

    191 units