BEUDAMED
    FDA Recall Terminated

    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

    Recall: Z-2160-2019 · Initiated June 18, 2019

    Recall

    Recall Number
    Z-2160-2019
    Event Number
    83345
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3004024955
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 18, 2019
    Terminated
    May 22, 2020
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

    Reason

    Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

    Action

    1. Please note this product has already been removed by your local Stryker Sales Representative and/or Stryker Branch or Agency. This communication is being made for notification purposes only; there are no additional product return requirements for this matter. 2. Please assist us in meeting our regulatory obligation by completing and signing the enclosed Product Recall Acknowledgment Form and email a copy to Stryker Spine at [email protected] or fax the form to 201-575-4675. If you have any questions, please contact Christa Joisil or Matthew Kelleher from the Regulatory Compliance Team: [email protected] or 201.749.8090

    Distribution

    US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX

    Quantity

    11