BEUDAMED
    FDA Enforcement Class II Ongoing

    Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01

    Recall: Z-2481-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2481-2023
    Event ID
    92839
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 6, 2023
    Initiation Date
    July 26, 2023
    Classification Date
    August 29, 2023
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01

    Reason

    A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

    Code Info

    UDI-DI: 04026575284658 Lot Codes: C010108, C151519

    Distribution

    IN,GA, TX

    Quantity

    6 units