Z-0498-06

Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at...

Name: Z-0498-06 Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at...
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 Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida... 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-0498-06
Status: Terminated
Initiated: 2005-10-14
Posted: 2006-02-07
Terminated: 2012-07-26
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Product is OPTEFIL Allograft Paste of varying sizes. 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 FedEx. 10/14/2005
Distribution: Products were distributed worldwide.
Product codes and lots: 3043361 3043362 3043364 3043365 3043366 3043367 3043368 3043369 3043370 3043441 3043443 3043445 3043446 3043471 3043472 3043473 3043475 3043476 3043477 3043479 3026931 3026932 3026934 3026935 3026937 3026939 3027181 3027185 3027187 3027189 3027462 3027463 3032194 3032196 3032200 3034771 3034776 3034777 3034779 3034780 3034851 3034852 3034853 3034854 3034855 3034857 3034858 3034859 3034860 3035411 3035412 3035414 3035415 3035416 3035417 3035418 3035420 3035951 3035952 3035953 3035954 3035959

Product code MQV

K043420Class IIOsteofil, Optefil, Regenafil, Rti Allograft PasteRegeneration Technologies, Inc. / cleared 2005-02-10

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)