Z-0123-2014Class II

Globus Medical MicroFuse Putty, 2.5cc and 10cc

Name: Z-0123-2014 Globus Medical MicroFuse Putty, 2.5cc and 10cc
Creator: Globus Medical, Inc.
Published: 2013-08-28
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2013-08-28 / Terminated / root cause: manufacturing process

FDA source

Globus Medical, Inc. began a recall of 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... on 2013-08-28. FDA classified it as Class II and gives the reason as "The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0123-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-28
Posted: 2013-10-31
Terminated: 2014-11-14
Recalling firm: Globus Medical, Inc.
Product: 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
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 193
Distribution: USA Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30

Product code MQV

K102392Class IIMicrofuse Putty and Microfuse St MisGlobus Medical, Inc. / cleared 2010-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)