Regeneration Technologies, Inc. Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Brand
Regeneration Technologies, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
2679850 2689160 2689162 2689164 2689167 2689370 2689377 2690296 2690298 2690302 2692920 2692925 2692931 2692932 2692933 2692934 2692935 2692936 2692937
Regeneration Technologies, Inc. is recalling Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled due to The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors canno. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Notification sent to all consignees by FedEx. 10/14/2005
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026