FDA Medical Device Recalls (openFDA)
Regeneration Technologies, Inc.: Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Recall number
- Z-0498-06
- Recalling firm
- Regeneration Technologies, Inc.
- Product
- Product is OPTEFIL Allograft Paste of varying sizes. 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
- 3043361 3043362 3043364 3043365 3043366 3043367 3043368 3043369 3043370 3043441 3043443 3043445 3043446 3043471 3043472 3043473 3043475 3043476 3043477 3043479 3026931 3026932 3026934 3026935 3026937 3026939 3027181 3027185 3027187 3027189 3027462 3027463 3032194 3032196 3032200 3034771 3034776 3034777 3034779 3034780 3034851 3034852 3034853 3034854 3034855 3034857 3034858 3034859 3034860 3035411 3035412 3035414 3035415 3035416 3035417 3035418 3035420 3035951 3035952 3035953 3035954 3035959
- 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