FDA Medical Device Recalls (openFDA)
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 number
- Z-0492-06
- Recalling firm
- Regeneration Technologies, Inc.
- Product
- Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Status
- Terminated
- Initiated
- 2005-10-14
- Posted
- 2006-02-07
- Terminated
- 2012-07-26
- Reason
- 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.
- Root cause
- Other
- Action
- Notification sent to all consignees by FedEx. 10/14/2005
- Quantity
- not on file
- Distribution
- Products were distributed worldwide.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K043420"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3002719998
- Firm city
- Alachua
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28