BEUDAMED
    FDA Enforcement Class II Ongoing

    Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

    Recall: Z-1307-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1307-2022
    Event ID
    90462
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    K2M, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    June 13, 2022
    Classification Date
    June 30, 2022
    Address
    600 Hope Pkwy Se, Leesburg, VA, 20175-4428, United States

    Description

    Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

    Reason

    Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.

    Code Info

    UDI-DI: 10888857326804 Lot PCMW

    Distribution

    Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.

    Quantity

    53 devices (19 US; 34 OUS)