BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0931-2021 · Initiated December 14, 2020

    Recall

    Recall Number
    Z-0931-2021
    Event Number
    87075
    FEI Number
    3008599177
    Product Code
    NKG
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 14, 2020
    Posted
    January 27, 2021
    Terminated
    July 11, 2023
    Address
    K2M Inc 600 Hope Pkwy SE, Leesburg, VA, 20175-4428

    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).

    Action

    On 12/14/2020, Stryker Spine US Field Operations were notified of the action by teleconference and e-mail and instructed to identify and return all Lot KRBX screws to Stryker Spine. Affected Stryker Branches/Agencies, and hospitals that had previously been consigned product, will be issued a formal recall notification letter and product return documentation.

    Distribution

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

    Quantity

    248 units/1 each