Date Initiated by Firm |
October 14, 2005 |
Date Posted |
February 07, 2006 |
Recall Status1 |
Terminated 3 on July 26, 2012 |
Recall Number |
Z-0492-06 |
Recall Event ID |
34004 |
510(K)Number |
K043420
|
Product Classification |
Filler, Bone Void, Calcium Compound - Product Code MQV
|
Product |
Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. |
Code Information |
2396521 2396522 2396523 2396524 2396525 2396526 2396527 2396528 2396529 2397301 2397302 2397303 2397304 2397305 2397306 2397307 2397308 2397309 2397310 2000878 2000879 2000880 2000881 2000882 2000883 2000884 2000885 2000886 2000887 2000888 2000889 2000890 2000891 2000892 2000893 2000894 2000895 2000896 2000897 2158322 2158324 2158325 2158326 2158327 2158329 |
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.
|