BEUDAMED
    FDA Enforcement Class I Terminated

    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.

    Recall: Z-0830-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0830-2013
    Event ID
    63783
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    January 4, 2013
    Classification Date
    February 15, 2013
    Termination Date
    May 20, 2014
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.

    Reason

    DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.

    Code Info

    Part number: 198720024 and Lot numbers: 113812, 123509, 140578, 156210, 171659, 171660, 171661, 171662, 171663, 123509A, B34GE1000, B34GEA000, B4EGR1000, B4EGRA000, B4EGRB000, B4XFL1000, B4XFLA000, B5SH11000, B5SH1A000, B5SH1B, C74J11000, D14KG1000, E4RF21000, EN8CY1000, EN8CYA000, FC1MB1, and FC1MBA.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.

    Quantity

    162 total units (US) and 102 units total (OUS)