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U.S. Department of Health and Human Services

Class 3 Device Recall Osteofil RT, ICM Allograft Paste

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 Class 3 Device Recall Osteofil RT, ICM Allograft Pastesee related information
Date Initiated by FirmOctober 14, 2005
Date PostedMarch 28, 2006
Recall Status1 Terminated 3 on August 07, 2012
Recall NumberZ-0703-06
Recall Event ID 34367
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
ProductOsteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2014947 2014949 2014952 2014953 2014954 2091152 2091153 2091154 2326261 2326262 2326263 2326265 2326267 2326268 2326269 2326270 2326761 2326762 2326764 2326767 2326769 2326770 2326801 2326802 2326803 2326804 2326805 2326806 2326806 2326807 2326808 2326809 2389440 2395012 2395013 2395014 2395015 2395016 2395017 2395018 2395019 2014945 2014946 2014948 2014950 2014951 2091151 2326264 2326763 2326765 2326766 2326810 2395011 2395020 2171680 2171681 2171682 2171683 2171684 2171685 2171686 2171687 2171688 2171690 2171692 2171693 2171694 2171695 2171696 2171697 2171698 2171700 2171702 2171703 2171704 2171705 2171706 2171707 2171708 2171709 2171710 2171711 2171712 2171713 2171689 2171691 2171699 2171701 
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
ActionNotification sent to all consignees by Fed Ex 10/14/2005.
Quantity in Commerce88
DistributionSpinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
Total Product Life CycleTPLC 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.
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