Recall Z-0501-06 ยท MQV Filler, Bone Void, Calcium Compound
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***''.
| Date | Feb 7, 2006 (initiated Oct 14, 2005) |
| Status | Terminated |
| 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 |
| Distribution | Products were distributed worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043421 | OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC Regeneration Technologies, Inc., Feb 16, 2005 |