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Class 2 Device Recall RTI Biologics BioSet IC RT Paste 2 cc |
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Date Initiated by Firm |
January 23, 2017 |
Create Date |
March 10, 2017 |
Recall Status1 |
Terminated 3 on April 05, 2018 |
Recall Number |
Z-1441-2017 |
Recall Event ID |
76473 |
510(K)Number |
K043421
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Product Classification |
Filler, bone void, calcium compound - Product Code MQV
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Product |
RTI Biologics BioSet IC RT Paste 2 cc
Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
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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. |
Recalling Firm/ Manufacturer |
RTI Surgical, Inc. 11621 Research Cir Alachua FL 32615-6825
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For Additional Information Contact |
Roxane Wergin 386-418-8888 Ext. 4414
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Manufacturer Reason for Recall |
Incorrect instructions for use (IFU) included.
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FDA Determined Cause 2 |
Labeling Change Control |
Action |
The 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 Commerce |
24 units |
Distribution |
International Distribution: Colombia only |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MQV and Original Applicant = REGENERATION TECHNOLOGIES, INC.
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