Z-2634-2011

Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615Distributed by: SpinalGraft...

Name: Z-2634-2011 ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft...
Creator: RTI Biologics, Inc.
Published: 2011-04-09
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2011-04-09 / Terminated / root cause: labeling and UDI

FDA source

RTI Biologics, Inc. began a recall of ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN... on 2011-04-09. The reason FDA records is "RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2634-2011
Status: Terminated
Initiated: 2011-04-09
Posted: 2011-06-23
Terminated: 2012-07-24
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118***OSTEOFIL DBM Paste, 5cc Tissue ID: 321933 Reorder: 002405 Lot #(Donor ID): 101050353 Expiration: 02/21/2013***STERILE***" Bone Void Filler used in spinal surgery.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this recall on 04/09/2011.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: RTI Biologics sent a "VOLUNTARY RECALL" letter dated April 9, 2008 to the one distributor, Spinal Graft Technologies. LLC. The letter describes the product, problem, and action to be taken by the distributor. The letter states that some of the product was issued a return authorization and requests that the distributor recover the remaining product from distribution. The recovered product will be issued a return authorization. RTI states the grafts can be returned in a non frozen state. Recall effectiveness will be determined by return of the product.
Quantity in commerce: 26 units
Distribution: Domestic Distribution--TN only.
Product codes and lots: 4179877, 4179878, 4179693, 4179694, 4179695, 4179696, 4179697, 4179698, 4179699, 4179870, 4179872, 4179873, 4179874, 4179875, 4179416, 4179417, 4179418, 4179419, 4179690, 3217933, 4179410, 4179411, 4179412, 4179413, 4179414.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)