BEUDAMED
    FDA Enforcement Class II Terminated

    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.

    Recall: Z-1190-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1190-2016
    Event ID
    73363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    February 12, 2016
    Classification Date
    March 18, 2016
    Termination Date
    August 11, 2016
    Address
    7375 Bush Lake Rd, N/A, Minneapolis, MN, 55439-2027, United States

    Description

    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.

    Reason

    Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).

    Code Info

    All lots

    Distribution

    US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.

    Quantity

    2506