BEUDAMED
    FDA Enforcement Class II 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 · Reported December 12, 2012

    Enforcement

    Recall Number
    Z-0474-2013
    Event ID
    63708
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2012
    Initiation Date
    November 1, 2012
    Classification Date
    December 4, 2012
    Termination Date
    August 29, 2013
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    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.

    Code Info

    Catalog Number: 113740 and Lot Number Identification: 779270

    Distribution

    USA Nationwide Distribution in the state of WI.

    Quantity

    4