Regeneration Technologies, Inc. Product is Regenafil IC. 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 Regenafil IC. 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
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
Regeneration Technologies, Inc. is recalling Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES 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