BEUDAMED
    FDA Recall Terminated

    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

    Recall: Z-1019-2016 · Initiated February 3, 2016

    Recall

    Recall Number
    Z-1019-2016
    Event Number
    73265
    Firm
    Zimmer Spine, Inc.
    FEI Number
    1000115775
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 3, 2016
    Terminated
    October 11, 2016
    Address
    7375 Bush Lake Rd, Minneapolis, MN, 55439-2027

    Description

    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

    Reason

    Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.

    Action

    Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to [email protected]. Questions or concerns can be directed to Customer Service at 1-866-774-6368

    Distribution

    Distributed US (nationwide) and in the countries of Australia and Germany.

    Quantity

    15,753