BEUDAMED
    FDA Enforcement Class II Terminated

    Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.

    Recall: Z-0520-2021 · Reported December 9, 2020

    Enforcement

    Recall Number
    Z-0520-2021
    Event ID
    86748
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 9, 2020
    Initiation Date
    November 3, 2020
    Classification Date
    December 2, 2020
    Termination Date
    January 12, 2021
    Address
    600 Hope Pkwy SE, N/A, Leesburg, VA, 20175-4428, United States

    Description

    Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.

    Reason

    Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

    Code Info

    Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948

    Distribution

    US Nationwide distribution.

    Quantity

    4 devices