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Globus Medical, Inc. recalls Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony
Recalled November 6, 2013 · FDA recall Z-0123-2014 · Globus Medical
Hazard
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. · FDA Class II
Units
193
Sold at
USA Nationwide Distribution.
Description
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
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
Manufacturer(s)
Globus Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →