FDA Medical Device Recalls (openFDA)
Regeneration Technologies, Inc.: Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Recall number
- Z-0497-06
- Recalling firm
- Regeneration Technologies, Inc.
- Product
- Product is 1.0cc flowable paste from donor approved for distribution in Italy. 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
- 2679850 2689160 2689162 2689164 2689167 2689370 2689377 2690296 2690298 2690302 2692920 2692925 2692931 2692932 2692933 2692934 2692935 2692936 2692937
- 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