BEUDAMED
    FDA Enforcement Class II Terminated

    Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

    Recall: Z-0931-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0931-2021
    Event ID
    87075
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 3, 2021
    Initiation Date
    December 14, 2020
    Classification Date
    January 27, 2021
    Termination Date
    July 11, 2023
    Address
    600 Hope Pkwy SE, Leesburg, VA, 20175-4428, United States

    Description

    Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

    Reason

    The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).

    Code Info

    Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582

    Distribution

    Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore

    Quantity

    248 units/1 each