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
This recall has been terminated (originally issued October 31, 2013).
- Company
- Globus Medical, Inc.
- Recall Initiated
- August 28, 2013
- Posted
- October 31, 2013
- Terminated
- November 14, 2014
- Recall Number
- Z-0123-2014
- Quantity
- 193
- Firm Location
- Audubon, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Distribution
USA Nationwide Distribution.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.