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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-0495-06
Recall Event ID 34004
510(K)Number K043421  
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Product is RTI Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2819380 2819382 2819383 2819384 2819386 2819387 2819388 2820151 2820153 2820154 2820156 2820157 2820158 2820159 2820281 2820282 2820283 2820284 2820285 2820286 2820287 2820288 2820289 2820341 2820343 2820520 2820521 2820523 2820525 2820526 2820527 2820528 2820529 2822391 2822392 2822393 2822394 2822395 2822396 2822397 2822398 2822840 2822841 2822844 2822845 2822846 2822847 2822849 2822860 2822861 2822862 2822863 2822864 2822865 2822867 2822868 2822869 2822990 2822991 2822992 2822995 2822997 2822998 2822999 2824351 2824356 2824358 2824359 2824972 2824974 2824976 2824977 2824980 2824981 2825230 2825231 2825233 2825234 2825235 2825236 2825238 2825239 2825310 2825312 2825313 2825314 2825315 2825317 2825318 2827841 2827842 2827843 2827844 2827846 2827847 2827848 2827849 2828930 2828931 2828932 2828934 2828935 2828936 2828937 2828938 2828939 2831133 2831135 2831136 2831139 2835180 2835182 2835183 2835184 2835185 2835186 2835188 2835189 2835471 2835479 2836210 2836211 2836212 2836214 2836215 2836216 2836218 2837142 2837143 2837144 2837145 2837147 2837148 2837149 2841740 2841741 2841742 2841743 2841744 2841746 2841747 2841748 2841811 2841812 2841813 2841816 2841819 2841822 2841824 2841825 2841829 2841860 2841863 2841864 2841865 2841869 2841980 2841981 2841984 2841988 2842860 2842861 2842863 2842864 2842865 2842866 2842867 2842868 2842869 2842880 2842881 2842883 2842884 2842885 2842889 2842901 2842903 2842905 2842909 1942715 1942716 1942717 1942719 1942720 1942721 1942722 2878543 2878544 2878545 2878546 2878548 2878549 1942714 2764410 2764411 2764412 2764413 2764414 2821780 2821781 2821782 2821783 2821784 2821785 2821786 2821787 2821788 2823650 2823651 2823652 2823653 2823654 2823655 2823656 2823657 2823658 2823659 2825130 2825131 2825132 2825133 2825134 2825135 2825136 2825137 2825138 2825139 2847641 2847643 2847649 2870100 2870101 2870102 2870103 2870104 2870105 2870106 2870107 2870108 2870109 2870454 2870455 2443516 2443520 2443741 2443745 2726490 2726491 2726492 2726493 2666749 2672330 2672332 2672390 2672391 2672393 2672394 2672395 2672396 2672397 2672398 2672399 2672400 2672401 2672402 2672403 2672404 2672405 2672406 2672407 2672409 2673830 2673831 2673832 2673833 2673834 2673835 2673836 2673839 2674111 2674112 2674113 2674114 2674116 2674117 2674118 2674119 2713227 2718751 2718752 2718757 2718759 2718792 2718933 2718938 2718963 2718967 2718968 
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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