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
Reported: November 6, 2013 Initiated: August 28, 2013 #Z-0123-2014
Product Description
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.
Details
- Recalling Firm
- Globus Medical, Inc.
- Units Affected
- 193
- Distribution
- USA Nationwide Distribution.
- Location
- Audubon, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Globus Medical, Inc.. Units affected: 193.
Why was this product recalled? ▼
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0123-2014.
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