Globus Medical MicroFuse Putty — Class II medical device recall Z-0123-2014
Terminated recall by Globus Medical, Inc., reported 2013-11-06, distributed nationwide. The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
| Recall number | Z-0123-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Globus Medical, Inc., Audubon, PA, United States |
| Recall initiated | 2013-08-28 |
| Classified | 2013-10-30 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-11-14 |
| Distributed | Nationwide (US) |
| Quantity | 193 |
| Reason classes | sterility |
| Lot numbers | GBN299BB, GBN319AB, GBN355AB |
| Model numbers | 838.202S, 838.210S |
| Expiration dates | 2013-10-20, 2013-11-20, 2013-12-20 |
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 for recall
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0123-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.