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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmOctober 14, 2005
Date PostedFebruary 07, 2006
Recall Status1 Terminated 3 on July 26, 2012
Recall NumberZ-0501-06
Recall Event ID 34004
510(K)NumberK043421 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
ProductProduct is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 2667987 2667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 2669636 2669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985 
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 FedEx. 10/14/2005
DistributionProducts were distributed worldwide.
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.
510(K) Database510(K)s with Product Code = MQV
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