FDA Medical Device Recalls (openFDA)
Regeneration Technologies, Inc.: Product is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
- Recall number
- Z-0501-06
- Recalling firm
- Regeneration Technologies, Inc.
- Product
- Product is 2.0 cc Opteform RT. 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
- 2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 2667987 2667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 2669636 2669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985
- 510(k) numbers
- ["K043421"]
- 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