BEUDAMED
    FDA Recall Terminated

    Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

    Recall: Z-0474-2013 · Initiated November 1, 2012

    Recall

    Recall Number
    Z-0474-2013
    Event Number
    63708
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 1, 2012
    Posted
    December 5, 2012
    Terminated
    August 29, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

    Reason

    The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.

    Action

    Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.

    Distribution

    USA Nationwide Distribution in the state of WI.

    Quantity

    4