Z-0698-06

Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES...

Name: Z-0698-06 Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES...
Creator: Regeneration Technologies, Inc.
Published: 2005-10-14
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2005-10-14 / Terminated / root cause: sterility

FDA source

Regeneration Technologies, Inc. began a recall of Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE... on 2005-10-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0698-06
Status: Terminated
Initiated: 2005-10-14
Posted: 2006-03-28
Terminated: 2012-08-07
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Product code: MQV Filler, Bone Void, Calcium Compound
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.
Root cause tag: sterility
FDA root cause: Other
Action: Notification sent to all consignees by Fed Ex 10/14/2005.
Quantity in commerce: 18
Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
Product codes and lots: 1766813 1766814 1890442 1890445 1890446 1890447 1890450 1890451 1938863 1938864 1938865 1938868 1938869 1890448 1890449 1938862 1938866 1938870

Product code MQV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)