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U.S. Department of Health and Human Services

Class 3 Device Recall Osteofil RT Allograft Paste

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 Class 3 Device Recall Osteofil RT Allograft Pastesee related information
Date Initiated by FirmOctober 14, 2005
Date PostedMarch 28, 2006
Recall Status1 Terminated 3 on August 07, 2012
Recall NumberZ-0698-06
Recall Event ID 34367
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
ProductOsteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 1766813 1766814 1890442 1890445 1890446 1890447 1890450 1890451 1938863 1938864 1938865 1938868 1938869 1890448 1890449 1938862 1938866 1938870 
FEI Number 3002719998
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 Commerce18
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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