BEUDAMED
    FDA Recall 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 · Initiated November 9, 2012

    Recall

    Recall Number
    Z-0527-2013
    Event Number
    63725
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 9, 2012
    Posted
    December 17, 2012
    Terminated
    August 28, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    On 11/9/2012 an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to all consignees (distributors and Doctor notices) informing them of the issue and providing recommended actions. Customer contact number (574) 372-1570 Monday through Friday from 8 am to 5 pm.

    Distribution

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

    Quantity

    49