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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 Recall
MicroFuse Bone Void Filler
see related information
Date Posted October 31, 2013
Recall Status1 Open
Recall Number Z-0123-2014
Recall Event ID 66266
Premarket Notification
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, Pennsylvania 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = GLOBUS MEDICAL INC.
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