BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952

    Recall: Z-0625-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0625-2016
    Event ID
    72832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    November 17, 2015
    Classification Date
    January 9, 2016
    Termination Date
    August 12, 2016
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952

    Reason

    Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.

    Code Info

    Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869

    Distribution

    US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.

    Quantity

    372