BEUDAMED
    FDA Enforcement Class II Terminated

    UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.

    Recall: Z-1380-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1380-2013
    Event ID
    64588
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthopedic Alliance LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    February 20, 2013
    Classification Date
    May 24, 2013
    Termination Date
    March 26, 2014
    Address
    26157 Jefferson Ave, N/A, Murrieta, CA, 92562-9561, United States

    Description

    UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.

    Reason

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

    Code Info

    Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050

    Distribution

    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

    Quantity

    57 units