BEUDAMED
    FDA Enforcement Class II Terminated

    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

    Recall: Z-1244-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1244-2014
    Event ID
    67618
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 26, 2014
    Initiation Date
    February 26, 2014
    Classification Date
    March 20, 2014
    Termination Date
    July 7, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

    Reason

    Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.

    Code Info

    Lot 239470, 457450

    Distribution

    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.

    Quantity

    6