BEUDAMED
    FDA Enforcement Class II Terminated

    Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.

    Recall: Z-1808-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1808-2018
    Event ID
    79991
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    August 7, 2017
    Classification Date
    May 11, 2018
    Termination Date
    August 23, 2018
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.

    Reason

    There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

    Code Info

    Lot 63688256, UDI (01)00889024247581(10)63688256; Lot 63576041, UDI (01)00889024247581(10)63576041; Lot 63531871, UDI (01)00889024247581(10)63531871

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.

    Quantity

    842 products in total