Globus Medical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0123-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
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

Product Classification:

Class II

Date Initiated: August 28, 2013
Date Posted: November 6, 2013
Recall Number: Z-0123-2014
Event ID: 66266
Reason for Recall:

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

Status: Terminated
Product Quantity: 193
Code Information:

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.

Distribution Pattern:

USA Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated