BEUDAMED
    FDA Recall Terminated

    Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.

    Recall: Z-2398-2016 · Initiated June 30, 2016

    Recall

    Recall Number
    Z-2398-2016
    Event Number
    74687
    Firm
    Zimmer Biomet Spine, Inc
    FEI Number
    3012447612
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 30, 2016
    Terminated
    March 15, 2017
    Address
    310 Interlocken Pkwy, Suite 120, Broomfield, CO, 80021-3479

    Description

    Zyston Transform Implant Kit. Model Number PCR8200-3101. 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.

    Action

    Verbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email notifications will also be sent to each recall notification addressee before distributing the recall documentation via Federal Express.

    Distribution

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

    Quantity

    5