BEUDAMED
    FDA Enforcement Class II Terminated

    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.

    Recall: Z-1189-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1189-2016
    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

    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.

    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

    3484