Reported Nov 6, 2013 · Terminated
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony…
Globus Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Globus Medical, Inc. · 2560 General Armistead Ave · Audubon, PA · 19403-5214
Is this the product you have?
- Globus Medical MicroFuse Putty, 2.5cc and 10cc
- Product UsageMicroFuse 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published — lot # GBN299BB and expiration date October 2013, and 838.210Slot #GBN355AB, with expiration date December 2013: and (10cc) with — lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013. - Amount recalled
- 193
Where it was sold
- Nationwide
Why it was recalled
The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
This product could cause temporary or reversible health problems — stop using it.
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