BEUDAMED
    FDA Recall Terminated

    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

    Recall: Z-1265-2016 · Initiated February 5, 2016

    Recall

    Recall Number
    Z-1265-2016
    Event Number
    73400
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 5, 2016
    Posted
    March 25, 2016
    Terminated
    March 28, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

    Reason

    The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary.

    Action

    On 2/5/2016, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors, hospital risk managers, and implanting surgeons via courier. Distributors were instructed to locate and return the affected product, hospitals to locate and discontinue use, and implanting surgeons to monitor patients. 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. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    UT Netherlands

    Quantity

    890