Z-0500-06

Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed...

Name: Z-0500-06 Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed...
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 OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua... 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-0500-06
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 OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. 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: 2956993 2956994

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)