BEUDAMED
    FDA Enforcement Class II Terminated

    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

    Recall: Z-0544-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0544-2013
    Event ID
    63690
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 26, 2012
    Initiation Date
    November 14, 2012
    Classification Date
    December 18, 2012
    Termination Date
    April 16, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    Description

    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.

    Reason

    All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

    Code Info

    Part Number 42-5320-083-01 TIBIA SIZE H, LEFT, Lot: 11006513, 11006722, 11007119, 62018828, 62018829, 62033403, 62060748, 62068423, 62076595, 62079771, 62091371, 62110207, 62117667 Part Number 42-5320-083-02 TIBIA SIZE H, RIGHT, Lot: 11007062, 11007123, 62018830, 62018831, 62033404, 62051804, 62060749, 62068424, 62076597, 62079772, 62091372, 62117668, 77001707

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.

    Quantity

    195