BEUDAMED
    FDA Enforcement Class II Terminated

    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.

    Recall: Z-1500-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1500-2021
    Event ID
    87665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nextremity Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 5, 2021
    Initiation Date
    March 26, 2021
    Classification Date
    April 27, 2021
    Termination Date
    November 10, 2021
    Address
    6210 N Buffalo St, N/A, Warsaw, IN, 46580, United States

    Description

    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.

    Reason

    Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended

    Code Info

    Lot Number: 168B29619A UDI: 00817701020868

    Distribution

    AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

    Quantity

    111 units