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U.S. Department of Health and Human Services

Class 3 Device Recall Osteofil IC Syringeable

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 Class 3 Device Recall Osteofil IC Syringeablesee related information
Date Initiated by FirmOctober 14, 2005
Date PostedMarch 28, 2006
Recall Status1 Terminated 3 on August 07, 2012
Recall NumberZ-0701-06
Recall Event ID 34367
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
ProductOsteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2185721 2185722 2185723 2185726 2185727 2185728 2185941 2185942 2185943 2185947 2185949 2185950 2250244 2185724 2185725 2185729 2185730 2185944 2185945 2185946 2185948 2141102 2141104 2141106 2141107 2141108 2141109 2141111 2141112 2141113 2141114 2141115 2141116 2141118 2141119 2141120 2141122 2141123 2141124 2141125 2141126 2157937 2157938 2157939 2157940 2157941 2157943 2157944 2157945 2141103 2141105 2141110 2141117 2141121 2157942 2157946 2250241 2250242 2250243 
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 Commerce59
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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