BEUDAMED
    FDA Recall 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 · Initiated August 28, 2013

    Recall

    Recall Number
    Z-0123-2014
    Event Number
    66266
    Firm
    Globus Medical, Inc.
    FEI Number
    3004142400
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 28, 2013
    Posted
    October 31, 2013
    Terminated
    November 14, 2014
    Address
    2560 General Armistead Ave, Audubon, PA, 19403-5214

    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.

    Action

    Globus sent an Urgent: Medical Device Recall Notification letter, dated August 28, 2013 to customers/users. The letter identified the affected units, issue, potential risk, product, and actions to be taken. Customers were requested to complete the attached response card and return of the affected product to Globus Medical. For questions and support contact Globus Medical by fax 1-610-300-1342 or email:[email protected].

    Distribution

    USA Nationwide Distribution.

    Quantity

    193