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Recall Observatory FDA recall evidence

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

August 28, 2013

Class II

Product summary

Firm
Globus Medical, Inc.
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

    reason.sterility_assurance · v1.0.0

    Sterility Assurance Level (SAL) of 10(-6) cannot be assured