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U.S. Department of Health and Human Services

Class 2 Device Recall MicroFuse Bone Void Filler

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  Class 2 Device Recall MicroFuse Bone Void Filler see related information
Date Initiated by Firm August 28, 2013
Date Posted October 31, 2013
Recall Status1 Terminated 3 on November 14, 2014
Recall Number Z-0123-2014
Recall Event ID 66266
510(K)Number K102392  
Product Classification Filler, bone void, calcium compound - Product Code MQV
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
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.
Recalling Firm/
Manufacturer		 Globus Medical, Inc.
2560 General Armistead Ave
Audubon PA 19403-5214
For Additional Information Contact Globus Medical Customer Service
610-930-1800
Manufacturer Reason
for Recall		 The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
FDA Determined
Cause 2		 Process control
Action Globus sent an Urgent: Medical Device Recall Notification letter, dated August 28, 2013 to customers/users. The letter identified the affected units, issue, potential risk, product, and actions to be taken. Customers were requested to complete the attached response card and return of the affected product to Globus Medical. For questions and support contact Globus Medical by fax 1-610-300-1342 or email:recall@globusmedical.com.
Quantity in Commerce 193
Distribution USA Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = GLOBUS MEDICAL INC.
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