FDA Medical Device Recalls (openFDA)
Regeneration Technologies, Inc.: Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Recall number
- Z-0701-06
- Recalling firm
- Regeneration Technologies, Inc.
- Product
- Osteofil IC Syringeable 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
- 2006-03-28
- 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
- 59
- Distribution
- Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
- Lot, serial or model codes
- 2185721 2185722 2185723 2185726 2185727 2185728 2185941 2185942 2185943 2185947 2185949 2185950 2250244 2185724 2185725 2185729 2185730 2185944 2185945 2185946 2185948 2141102 2141104 2141106 2141107 2141108 2141109 2141111 2141112 2141113 2141114 2141115 2141116 2141118 2141119 2141120 2141122 2141123 2141124 2141125 2141126 2157937 2157938 2157939 2157940 2157941 2157943 2157944 2157945 2141103 2141105 2141110 2141117 2141121 2157942 2157946 2250241 2250242 2250243
- 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