BEUDAMED
    FDA Enforcement Class II Ongoing

    SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

    Recall: Z-0100-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0100-2023
    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

    SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

    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): 00810633020111 Lot/Expiry MSE210240 7/1/2027

    Distribution

    US Nationwide distribution.

    Quantity

    96