BEUDAMED
    FDA Recall Terminated

    Persona Partial Knee System, Size 8, Finishing Guide

    Recall: Z-0349-2018 · Initiated July 5, 2017

    Recall

    Recall Number
    Z-0349-2018
    Event Number
    78725
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 5, 2017
    Terminated
    April 2, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Persona Partial Knee System, Size 8, Finishing Guide

    Reason

    Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.

    Action

    Customers were notified via FedEx mail and email on approximately 07/05/2017. Instructions included to notify appropriate personnel, complete and return the Acknowledgement Form, return affected product, and provide contact information of additional hospitals or surgeons that used the affected product.

    Distribution

    Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.

    Quantity

    158 devices