BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1019-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1019-2016
    Event ID
    73265
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    February 3, 2016
    Classification Date
    February 26, 2016
    Termination Date
    October 11, 2016
    Address
    7375 Bush Lake Rd, N/A, Minneapolis, MN, 55439-2027, United States

    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.

    Code Info

    Surgical Technique Manual L1637 Rev B (2014-06)

    Distribution

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

    Quantity

    15,753