BEUDAMED
    FDA Enforcement Class II Terminated

    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

    Recall: Z-2397-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2397-2016
    Event ID
    74687
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet Spine, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    August 17, 2016
    Initiation Date
    June 30, 2016
    Classification Date
    August 11, 2016
    Termination Date
    March 15, 2017
    Address
    310 Interlocken Pkwy, Suite 120, Broomfield, CO, 80021-3479, United States

    Description

    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

    Reason

    Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.

    Code Info

    Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.

    Distribution

    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.

    Quantity

    5