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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall 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-0493-06
Recall Event ID 34004
510(K)Number K043420  
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 3047051 3047052 3047053 3047054 3047055 3047056 3047057 3047058 3047059 3047060 3049351 3049352 3049353 3049354 3049355 3049356 3049357 3049358 3049359 3049360 3049421 3049422 3049423 3049424 3049425 3049426 3049427 3049428 3049429 3049430 3049471 3049472 3049473 3049474 3049475 3049476 3049477 3049478 3049479 3049480 3056740 3056817 3056818 3056819 3056820 3056981 3056982 3056983 3056984 3056985 3056986 3056987 3056988 3056989 3056990 3057141 3057142 3057143 3057144 3057145 3057146 3057147 3057148 3057149 3057150 3057161 3057162 3057163 3057165 3057166 3057167 3057168 3057169 3057170 3057241 3057242 3057243 3057244 3057245 3057246 3057248 3057249 3057250 3057251 3057252 3057253 3057254 3057255 3057256 3057257 3057258 3057259 3057260 3057281 3057282 3057283 3057284 3057285 3057286 3057287 3057288 3057289 3057290 3057915 3057917 3057918 3057919 3057920 3057921 3057922 3057923 3057924 3057985 3057986 3057987 3057988 3057989 3057990 3057991 3057992 3057993 3057994 3059151 3059152 3059153 3059154 3059155 3059156 3059157 3059158 3059159 3059160 3059521 3059522 3059523 3059524 3059525 3059526 3059527 3059528 3059529 3059530 3059621 3059622 3059623 3059624 3059625 3059626 3059627 3059628 3059629 3059630 3060574 3060575 3060576 3064501 3064502 3064503 3064504 3064505 3064506 3064507 3064508 3064509 3064510 3064561 3064562 3064563 3064564 3064565 3064566 3064567 3064568 3064569 3064570 3064761 3064762 3064763 3064764 3064765 3064766 3064767 3064768 3064769 3064770 3064781 3064782 3064783 3064785 3064786 3064787 3064788 3064789 3064790 3064821 3064822 3064823 3064824 3064826 3064827 3064828 3064829 3064830 3064881 3064882 3064884 3064885 3064886 3064887 3064888 3064889 
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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