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U.S. Department of Health and Human Services

Class 3 Device Recall 1.0cc Regenaform RT.

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  Class 3 Device Recall 1.0cc Regenaform RT. see related information
Date Initiated by Firm October 14, 2005
Date Posted February 07, 2006
Recall Status1 Terminated 3 on July 26, 2012
Recall Number Z-0481-06
Recall Event ID 34004
510(K)Number K043420  
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Product is 1.0 cc Regenaform¿ RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 2879138 2879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 2879441 2879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 2879450 2879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 2879459 2886780 2886781 2886782 2886783 2886784 2886785 2886786 2886787 2886788 2886789 2886950 2886951 2886952 2886953 2886954 2886955 2886956 2886957 2886958 2886959 2962280 2962281 2962282 2962283 2962284 2962285 2962286 2962287 2962288 2962289 2963820 2963821 2963822 2963823 2963824 2963825 2963826 2963827 2963828 2963829 2963910 2963911 2963912 2963913 2963914 2963915 2963916 2963917 2963918 2963919 2963990 2963991 2963992 2963993 2963994 2963995 2963996 2963997 2963998 2963999 2965900 2965901 2965902 2965903 2965904 2965905 2965906 2965907 2965908 2965909 2965910 2965911 2965912 2965913 2965914 2965915 2965916 2965917 2965918 2974861 2974862 2974863 2974864 2974865 2974866 2974867 2974868 2974869 2974870 3021827 3021829 3021830 3021831 3021832 3021833 3021834 3021836 3021877 3021878 3021882 3021883 3021885 3023281 3023282 3023283 3023284 3023285 3023286 3023287 3023288 3023289 3030571 3030572 3030573 3030574 3031471 3031473 3031474 3031475 3031476 3031477 3031478 3031479 3031480 
Recalling Firm/
Manufacturer		 Regeneration Technologies, Inc.
11621 Research Circle
Alachua FL 32615
Manufacturer Reason
for Recall		 The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
FDA Determined
Cause 2		 Other
Action Notification sent to all consignees by FedEx. 10/14/2005
Distribution Products were distributed worldwide.
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 = REGENERATION TECHNOLOGIES, INC.
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