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
FDA Recall Z-0123-2014 · Posted 2013-10-31
Recalling FirmGlobus Medical, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2013-08-28
Date Terminated2014-11-14
Product Quantity193
Reason for Recall
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Firm Action
Globus sent an Urgent: Medical Device Recall Notification letter, dated August 28, 2013 to customers/users. The letter identified the affected units, issue, potential risk, product, and actions to be taken. Customers were requested to complete the attached response card and return of the affected product to Globus Medical. For questions and support contact Globus Medical by fax 1-610-300-1342 or email:[email protected].
Root Cause
Process control
Distribution Pattern
USA Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.