BEUDAMED
    FDA Recall Terminated

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    Recall: Z-0069-2017 · Initiated September 23, 2016

    Recall

    Recall Number
    Z-0069-2017
    Event Number
    75297
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3008002452
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    September 23, 2016
    Terminated
    May 10, 2019
    Address
    1500 S Waukegan Rd, Waukegan, IL, 60085-6728

    Description

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    Reason

    Potential risk associated with corrosion demonstrated on the distraction screw surface.

    Action

    On September 23, 2016, Becton Dickinson sent a Field Safety Notice to all affected customers describing the details of the recall and necessary action to take. ACTIONS TO BE TAKEN BY BD: A credit will be applied to your account for the affected product upon receipt of the affected unit(s) or receipt of certification of destruction documented on the customer response form. Complete the Recall Response form certifying that all affected product in your inventory has been destroyed and mail/email a copy of the response form.: The firm requests customers to promptly return the enclosed response form to expedite the correction process and acknowledge receipt of this notification. Or email: [email protected] For further questions, please call (847) 473-1500.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.

    Quantity

    72,076 units