Recall Z-0123-2014— Globus Medical, Inc.

Name: FDA recall Z-0123-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-28

Class II · Terminated

Class II FDA medical device recall by Globus Medical, Inc., initiated 2013-08-28, terminated 2014-11-14. It names one FDA 510(k) clearance: K102392. 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. Reason: The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured..

Recalling firm: Globus Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-28
Terminated: 2014-11-14
Firm location: Audubon, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K102392 — MICROFUSE PUTTY AND MICROFUSE ST MISGlobus Medical, Inc.·cleared 2010-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.