Class II — Globus Medical, Inc.
| Recalling firm | Globus Medical, Inc |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Quantity | 193 |
| Distribution | USA Nationwide Distribution. |
| Initiated | 2013-08-28 |
| Classified | 2013-10-30 |
| Terminated | 2014-11-14 |
| Recall number | Z-0123-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Globus Medical, Inc. (Z-0123-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66266/
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