FDA Device recall Z-0123-2014
Globus Medical MicroFuse Putty, 2.5cc and 10cc
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Globus Medical MicroFuse Putty, 2.5cc and 10cc by Globus Medical, citing the sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0123-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-28 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Globus Medical |
| Distribution | US |
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
Reason
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Identifiers
| code_info | Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2014%22
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