BEUDAMED
    FDA Enforcement Class II Terminated

    LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

    Recall: Z-1672-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1672-2015
    Event ID
    71085
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 3, 2015
    Initiation Date
    March 4, 2015
    Classification Date
    May 26, 2015
    Termination Date
    October 30, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

    Reason

    The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

    Code Info

    All Lots. Catalog numbers: 129411010 129411020 129411030 129411040 129411050 129411060 129411070 129412010 129412020 129412030 129412040 129412050 129412060 129412070 129495040 129495050 129495060 129496040 129496050 129496060

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.

    Quantity

    19,059