BEUDAMED
    FDA Enforcement Class II Ongoing

    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15

    Recall: Z-1554-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1554-2023
    Event ID
    92088
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Linkbio Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 10, 2023
    Initiation Date
    March 21, 2023
    Classification Date
    May 4, 2023
    Address
    101 Round Hill Dr Ste 7, Rockaway, NJ, 07866-1214, United States

    Description

    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15

    Reason

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Code Info

    UDI-DI: 04026575436750 All lot numbers within the labeled expiration date

    Distribution

    NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus

    Quantity

    5 units