BEUDAMED
    FDA Enforcement Class II Terminated

    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.

    Recall: Z-0596-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0596-2018
    Event ID
    79103
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    August 28, 2017
    Classification Date
    February 13, 2018
    Termination Date
    August 23, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.

    Reason

    Potential for the Persona Partial Knee Impactor Pad to fracture.

    Code Info

    Item No. 42539909100; Lot No. (UDI No.): 63517759 ((01) 00880304810242 (10) 63517759), 63555750 ((01) 00880304810242 (10) 63555750), 63555752 ((01) 00880304810242 (10) 63555752), 63561883 ((01) 00880304810242 (10) 63561883), 63561884 ((01) 00880304810242 (10) 63561884), 63594911((01) 00880304810242 (10) 63594911), 63594914 ((01) 00880304810242 (10) 63594914), 63698564 ((01) 00880304810242 (10) 63698564), 63705328 ((01) 00880304810242 (10) 63705328)

    Distribution

    US Nationwide Distribution in the states of 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, Switzerland, UK.

    Quantity

    1,275 units total