BEUDAMED
    FDA Recall 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-0828-2013 · Initiated January 4, 2013

    Recall

    Recall Number
    Z-0828-2013
    Event Number
    63783
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 4, 2013
    Posted
    February 15, 2013
    Terminated
    May 20, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    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.

    Action

    DePuy Othopaedics sent an Urgent Information Medical Device Recall Notice letter dated January 4, 2013 to all affected customers. The letter identified the affected products, reason for recall, clinical implications and actions to be taken. The letter instructed customers to check inventory, discontinue use, cease further distribution and return all inventory on hand for credit. Customers were requested to complete and return the Reconciliation Form. For product-related questions contact your local DePuy Othopaedics Sales Representative, clinical questions contact DePuy's Scientific Information Office at 1-888-554-2482 and recall notice information call 574-372-7333.

    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)