Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES,
FDA device recall Z-0493-06 · posted 2006-02-07 · Terminated
Recall details
- Recalling firm
- Regeneration Technologies, Inc.
- Reason for recall
- 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.
- Action taken
- Notification sent to all consignees by FedEx. 10/14/2005
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Distribution
- Products were distributed worldwide.
- Date initiated
- 2005-10-14
- Date posted
- 2006-02-07
- Date terminated
- 2012-07-26
- Location
- Alachua, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (K043420) | Regeneration Technologies, Inc. | 2005-02-10 |