Z-0703-06

Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at...

Name: Z-0703-06 Osteofil RT, ICM Allograft Paste in 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 Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE... 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-0703-06
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, ICM Allograft Paste in 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 Fed Ex 10/14/2005.
Quantity in commerce: 88
Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
Product codes and lots: 2014947 2014949 2014952 2014953 2014954 2091152 2091153 2091154 2326261 2326262 2326263 2326265 2326267 2326268 2326269 2326270 2326761 2326762 2326764 2326767 2326769 2326770 2326801 2326802 2326803 2326804 2326805 2326806 2326806 2326807 2326808 2326809 2389440 2395012 2395013 2395014 2395015 2395016 2395017 2395018 2395019 2014945 2014946 2014948 2014950 2014951 2091151 2326264 2326763 2326765 2326766 2326810 2395011 2395020 2171680 2171681 2171682 2171683 2171684 2171685 2171686 2171687 2171688 2171690 2171692 2171693 2171694 2171695 2171696 2171697 2171698 2171700 2171702 2171703 2171704 2171705 2171706 2171707 2171708 2171709 2171710 2171711 2171712 2171713 2171689 2171691 2171699 2171701

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)