Recall Z-0123-2014 ยท MQV Filler, Bone Void, Calcium Compound
Globus Medical, Inc.
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
| Date | Oct 31, 2013 (initiated Aug 28, 2013) |
| Status | Terminated |
| Reason | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. |
| Root cause | Process control |
| 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:recall@globusmedical.com. |
| Quantity | 193 |
| Distribution | USA Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102392 | MICROFUSE PUTTY AND MICROFUSE ST MIS Globus Medical, Inc., Dec 22, 2010 |