Device product
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
Z-0123-2014
Product summary
- Event
- Event 66266
- Status
- Terminated
- Classification
- Class II
- Quantity
- 193
- Official record key
device-enforcement:Z-0123-2014
Official wording
Reason: The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Code information: 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.
Distribution pattern: USA Nationwide Distribution.
Derived failure modes
-
Sterility assurance
Sterility Assurance Level (SAL) of 10(-6) cannot be assured