BEUDAMED
    FDA Recall Terminated

    Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 4, sterile; Part number 1498-24-004.

    Recall: Z-0462-2007 · Initiated November 15, 2006

    Recall

    Recall Number
    Z-0462-2007
    Event Number
    36849
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    HRY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 15, 2006
    Posted
    January 11, 2007
    Terminated
    April 30, 2008
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 4, sterile; Part number 1498-24-004.

    Reason

    Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.

    Action

    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.

    Distribution

    Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.

    Quantity

    558 for Recalls Z-0456-0465-2007