BEUDAMED
    FDA Recall Terminated

    REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.

    Recall: Z-1833-2011 · Initiated February 10, 2011

    Recall

    Recall Number
    Z-1833-2011
    Event Number
    58025
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    February 10, 2011
    Posted
    March 28, 2011
    Terminated
    May 16, 2011
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.

    Reason

    Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.

    Action

    The firm, Biomet, sent a "FIELD SAFETY NOTICE" dated February 11, 2011 to all customers (heads of Orthopaedic Departments/Operating Departments /Sterile Services Departments/Procurement /Supplies/ Risk Management). The notice described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the product; return to Biomet or their local Biomet distributor; ensure that the operating staff are made aware of this issue, and complete and return the FAX BACK RESPONSE FORM to Biomet UK Ltd or their local Biomet distributor via fax at +44 (0) 1656 645454. If you have any questions regarding this communication, please contact the Regulatory & Compliance Manager at +44 (0) 1793 645317 or email: [email protected].

    Distribution

    Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland.

    Quantity

    17