BEUDAMED
    FDA Recall Terminated

    Zeus-P Lumbar Interbody Device

    Recall: Z-0827-2017 · Initiated November 22, 2016

    Recall

    Recall Number
    Z-0827-2017
    Event Number
    75855
    Firm
    Amendia, Inc
    FEI Number
    3007970248
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    November 22, 2016
    Posted
    December 20, 2016
    Terminated
    June 5, 2017
    Address
    1755 W Oak Pkwy, Marietta, GA, 30062-2260

    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.

    Action

    Amendia Inc. sent an Urgent - Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions please call (404) 610-7215.

    Distribution

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

    Quantity

    25 units