BEUDAMED
    FDA Enforcement Class II Ongoing

    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

    Recall: Z-1574-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1574-2023
    Event ID
    92142
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2023
    Initiation Date
    November 19, 2021
    Classification Date
    May 10, 2023
    Address
    1800 Pyramid Pl, N/A, Memphis, TN, 38132-1703, United States

    Description

    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

    Reason

    Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.

    Code Info

    UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103

    Distribution

    US: IN, CT, NE

    Quantity

    4 units