BEUDAMED
    FDA Enforcement Class II Terminated

    EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

    Recall: Z-0527-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0527-2013
    Event ID
    63725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    November 9, 2012
    Classification Date
    December 17, 2012
    Termination Date
    August 28, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

    Reason

    It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

    Code Info

    Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)

    Distribution

    Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.

    Quantity

    49