CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

MicroFuse Putty, 2.5cc and 10cc recalled by Globus Medical

Globus Medical is recalling MicroFuse Putty, 2.5cc and 10cc, distributed nationwide in the US. The recall was initiated on 28 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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.

Quantity recalled193

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0123-2014
FDA event ID: 66266
Recalling firm: Globus Medical, Audubon, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2013
FDA classified: 30 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

28 Aug 2013	Recall initiated by company
30 Oct 2013	Classified by FDA	+63 days
6 Nov 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

USA Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

USA Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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