BEUDAMED
    FDA Enforcement Class II Terminated

    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

    Recall: Z-1701-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1701-2015
    Event ID
    71202
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer CAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    April 19, 2015
    Classification Date
    June 2, 2015
    Termination Date
    May 13, 2016
    Address
    75 Queen St #3300, N/A, Montreal, N/A, N/A, Canada

    Description

    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

    Reason

    Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.

    Code Info

    Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135

    Distribution

    Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.

    Quantity

    78 devices