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U.S. Department of Health and Human Services

Class 2 Device Recall RTI Biologics BioSet IC RT Paste 2 cc

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 Class 2 Device Recall RTI Biologics BioSet IC RT Paste 2 ccsee related information
Date Initiated by FirmJanuary 23, 2017
Create DateMarch 10, 2017
Recall Status1 Terminated 3 on April 05, 2018
Recall NumberZ-1441-2017
Recall Event ID 76473
510(K)NumberK043421 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductRTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Code Information Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
FEI Number 3002719998
Recalling Firm/
Manufacturer		 RTI Surgical, Inc.
11621 Research Cir
Alachua FL 32615-6825
For Additional Information ContactRoxane Wergin
386-418-8888 Ext. 4414
Manufacturer Reason
for Recall		Incorrect instructions for use (IFU) included.
FDA Determined
Cause 2		Labeling Change Control
ActionThe firm, RTI Surgical, Inc., issued and "IMPORTANT NOTIFICATION Field Action" letter dated January 20th, 2017 to its consignee via e-mail on 01/23/2017. Verification and confirmation of the e-mail was received on the same date. The letter described the product, problem and actions to be taken. The consignee were instructed to immediately quarantine any grafts in your possession; return any unused RTI and include return authorization along with instructions on how to return the product. If you have any questions, Sr. Manager, Regulatory Compliance at 386-418-8888 ext. 4396 or email: amcconnell@rtix.com.
Quantity in Commerce24 units
DistributionInternational Distribution: Colombia only
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQV
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