BEUDAMED
    FDA Recall Terminated

    LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.

    Recall: Z-1673-2015 · Initiated March 4, 2015

    Recall

    Recall Number
    Z-1673-2015
    Event Number
    71085
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    NJL
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 4, 2015
    Posted
    May 26, 2015
    Terminated
    October 30, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    LCS COMPLETE RPS inserts, various sizes. 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.

    Action

    On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).

    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

    28,732