Recall Z-0700-06 ยท MQV Filler, Bone Void, Calcium Compound
Regeneration Technologies, Inc.
Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
| Date | Mar 28, 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 Fed Ex 10/14/2005. |
| Quantity | 235 |
| Distribution | Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.