FDA Medical Device Recalls (openFDA)
Regeneration Technologies, Inc.: Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Recall number
- Z-0699-06
- Recalling firm
- Regeneration Technologies, Inc.
- Product
- Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Status
- Terminated
- Initiated
- 2005-10-14
- Posted
- 2006-03-28
- Terminated
- 2012-08-07
- 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 Fed Ex 10/14/2005.
- Quantity
- 55
- Distribution
- Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
- Lot, serial or model codes
- 1678712 1678713 1678714 1678715 1678716 1678718 2086922 2086924 2086925 2115381 2115382 2115383 2115384 2115385 2115387 2115388 2115389 2115390 2116581 2116582 2116585 2116586 2116587 2116588 2116589 2116590 2116762 2116764 2116766 2116767 2116768 2116771 2116892 2116893 2116894 2116895 2116896 2116897 2116898 2116899 2116900 2116901 1678711 1678717 1678719 1678720 2086921 2086923 2115386 2116583 2116584 2116763 2116765 2116769 2116770
- 510(k) numbers
- not on file
- 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