Date Initiated by Firm |
October 14, 2005 |
Date Posted |
February 07, 2006 |
Recall Status1 |
Terminated 3 on July 26, 2012 |
Recall Number |
Z-0491-06 |
Recall Event ID |
34004 |
510(K)Number |
K043420
|
Product Classification |
Filler, Bone Void, Calcium Compound - Product Code MQV
|
Product |
OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. |
Code Information |
2726001 2726002 2726003 2730281 2730282 2730283 |
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.
|