BEUDAMED
    FDA Recall Terminated

    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

    Recall: Z-0703-2017 · Initiated November 8, 2016

    Recall

    Recall Number
    Z-0703-2017
    Event Number
    75608
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    NJL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 8, 2016
    Posted
    December 3, 2016
    Terminated
    June 5, 2017
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

    Reason

    DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.

    Action

    DePuy Orthopaedics, Inc. initiated a voluntary recall on 11/8/2016 via letter mailed to the customer. Only one device was distributed in the U.S., and this was removed from the hospital on 21-Oct-2016. This recall does not affect any other lots of the LCS Complete Knee Revision System VVC Insert Small 22.5mm devices. The recall notice provides instructions for notifying the medical facility that received, used, or purchased the affected lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm. The purpose of this device recall is to notify medical professionals of the possible effects of using the affected device and to communicate that there are no recalled devices distributed at this time. The customer was asked to do the following: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or email to [email protected] within five (5) business-days of this notice. " Retain a copy of the completed Reconciliation Form and this notice in your files. " Forward this notice to others in your facility that need to be informed. Effectiveness will be determined by the return of one US Medical Facility Reconciliation Form. For questions about device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 or [email protected] or [email protected].

    Distribution

    US Distribution in the state of TN

    Quantity

    1