BEUDAMED
    FDA Enforcement Class II Terminated

    Zeus-P Lumbar Interbody Device

    Recall: Z-0827-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0827-2017
    Event ID
    75855
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amendia, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    November 22, 2016
    Classification Date
    December 20, 2016
    Termination Date
    June 5, 2017
    Address
    1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States

    Description

    Zeus-P Lumbar Interbody Device

    Reason

    Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.

    Code Info

    Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946

    Distribution

    US Distribution to the states of : GA. MI, OK, SC, TX, VA

    Quantity

    25 units