Events

Recall of Device Recall MicroFuse Bone Void Filler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Globus Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66266
  • Event Risk Class
    Class 2
  • Event Number
    Z-0123-2014
  • Event Initiated Date
    2013-08-28
  • Event Date Posted
    2013-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121916
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filler, bone void, calcium compound - Product Code MQV
  • 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:recall@globusmedical.com.

Device

Device Recall MicroFuse Bone Void Filler
  • Model / Serial
    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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution.
  • Product 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
  • Manufacturer
    Globus Medical, Inc.

Manufacturer

Globus Medical, Inc.
  • Manufacturer Address
    Globus Medical, Inc., 2560 General Armistead Ave, Audubon PA 19403-5214
  • Manufacturer Parent Company (2017)
    Globus Medical, Inc.
  • Source
    USFDA