FDA Device

Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Hazard

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.

What You Should Do

Remedy

Notification sent to all consignees by Fed Ex 10/14/2005.

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Products

Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Brand
Regeneration Technologies, Inc.
UPC
1766813 1766814 1890442 1890445 1890446 1890447 1890450 1890451 1938863 1938864 1938865 1938868 1938869 1890448 1890449 1938862 1938866 1938870

Units Affected

18

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