FDAFDA · Food and drugs·Recall number Z-0123-2014
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
Published November 6, 2013 · Recall initiated: August 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Globus Medical, Inc.
- Distributor
- USA Nationwide Distribution.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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