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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-0488-06
Recall Event ID 34004
510(K)Number K043421  
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2511671 2511672 2511673 2511674 2511675 2511676 2511677 2511678 2614471 2614472 2614473 2614474 2614475 2614721 2614722 2614723 2614724 2614725 2614726 2614727 2614728 2730530 2730531 2730532 2730533 2730534 2730535 2730536 2730537 2742463 2742464 2742465 2742466 2746363 2746364 2746365 2746366 2746367 2746368 2746369 2747870 2764991 2764992 2764993 2764994 2764995 2764996 2764997 2764998 2764999 2766699 2766700 2766701 2766702 2766703 2766704 2924612 2924613 2924730 2924731 2924732 2924733 2924734 2924735 2924736 2924737 2924738 2924739 2184631 2184633 2184634 2184635 2184636 2184637 2184638 2184639 2184640 2185751 2185752 2185753 2185754 2185755 2185756 2185757 2185758 2185759 2185760 2275371 2275372 2275373 2275374 2275375 2275376 2275377 2275378 2275379 2275380 2277521 2277522 2277523 2277524 2277525 2277526 2277527 2277528 2697923 2697924 2697925 2697926 2697927 2697928 2697929 2699572 2699573 2699574 2699575 2699576 2699577 2699732 2699733 2699734 2699735 2699736 2699737 2699738 2701392 2701393 2703640 2703961 2703962 2703963 2703964 2703965 2703966 2703967 2730383 2730384 2730385 2730386 2730387 2730388 2749681 2749682 2749683 2749684 2749685 2749686 2749687 2749688 2754459 2754460 2754461 2754462 2754463 2788895 2788896 2788897 2894236 2924780 2924781 2924782 2924783 2924784 2924785 2924786 2924787 2924788 2924933 2926150 2926151 2926152 2926153 2926154 2926155 2926156 2926157 2926158 2926159 2945532 2945533 2945534 2945535 2945536 2945537 2945538 2946230 2946231 2946232 2946233 2946234 2946235 2946236 2946237 2946238 2946239 2946350 2946351 2946352 2946353 2946354 2946355 2946356 2946357 2946358 2946359 2955822 2955823 2955824 2955825 2955826 2955827 2955828 2955829 2959010 2959011 2959012 2959013 2959014 2959015 2959016 2959017 2959018 2959019 2964612 2964613 2964614 2985046 2985048 2985049 2985112 2985113 2985114 2985115 2985116 2985117 2985118 2985119 2985120 2985393 3003673 3003674 3003675 3003676 3003677 3003678 
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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