Z-0701-06

Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration...

Name: Z-0701-06 Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration...
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 IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT... 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-0701-06
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 IC Syringeable 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 Fed Ex 10/14/2005.
Quantity in commerce: 59
Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
Product codes and lots: 2185721 2185722 2185723 2185726 2185727 2185728 2185941 2185942 2185943 2185947 2185949 2185950 2250244 2185724 2185725 2185729 2185730 2185944 2185945 2185946 2185948 2141102 2141104 2141106 2141107 2141108 2141109 2141111 2141112 2141113 2141114 2141115 2141116 2141118 2141119 2141120 2141122 2141123 2141124 2141125 2141126 2157937 2157938 2157939 2157940 2157941 2157943 2157944 2157945 2141103 2141105 2141110 2141117 2141121 2157942 2157946 2250241 2250242 2250243

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)