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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-0499-06
Recall Event ID 34004
510(K)Number K043420  
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2984056 2984062 2984064 2984065 2984067 2986825 2986827 2986829 2995321 2995322 2995323 2995324 2995325 2995326 2995327 2995328 2995329 2995330 2999692 2999693 2999694 2999695 2999696 2999697 2999698 2999699 2999700 2999924 2999925 2999926 2999927 2999928 2999929 2713387 2718732 2718736 2718737 2718738 2559751 2559752 2559753 2559754 2559755 2559756 2559757 2559758 2559759 2559760 2560031 2560032 2560033 2560034 2560035 2560036 2560037 2560038 2560039 2560040 2560271 2560272 2610521 2610522 2610523 2610524 2610525 2610526 2610527 2610528 2610529 2610530 2610541 2610542 2610543 2610544 2610545 2610546 2610547 2610548 2610549 2610550 2610581 2610582 2610583 2610584 2610585 2610586 2610601 2610602 2610603 2610604 2610605 2610606 2610607 2610608 2610609 2610610 2610611 2610612 2610613 2610614 2610615 2610616 2610617 2610618 2610619 2610620 2610761 2610762 2610763 2610764 2610765 2610766 2610767 2610768 2610769 2610770 2666740 2666741 2666742 2666743 2666744 2666745 2666746 2666747 2666748 
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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