BEUDAMED
    FDA Enforcement Class II Terminated

    Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft

    Recall: Z-0123-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0123-2014
    Event ID
    66266
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Globus Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    August 28, 2013
    Classification Date
    October 30, 2013
    Termination Date
    November 14, 2014
    Address
    2560 General Armistead Ave, N/A, Audubon, PA, 19403-5214, United States

    Description

    Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft

    Reason

    The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.

    Code Info

    Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013.

    Distribution

    USA Nationwide Distribution.

    Quantity

    193