BEUDAMED
    FDA Recall Terminated

    ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height

    Recall: Z-0812-2015 · Initiated September 29, 2014

    Recall

    Recall Number
    Z-0812-2015
    Event Number
    69662
    FEI Number
    3009189869
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 29, 2014
    Posted
    December 16, 2014
    Terminated
    June 27, 2016
    Address
    6710 Reseach Rd., Inc. 4-Web Suite # 219, Frisco, TX, 75033

    Description

    ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height

    Reason

    Product is mislabeled.

    Action

    4Web Medical sent an Urgent Medical Device Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm does not require any action to be performed by the consignees.The firm plans to label the remaining recalled lot not distributed as , "samples". Please contact 4Web Customer Service for questions and support. Phone: (1-800) 285-7090 Hours: Monday through Friday, 8:00am to 5:00pm Central Standard time.

    Distribution

    US Distribution including the states of TX, MT, DC, CA, IL, and MD.

    Quantity

    35 units