Recall Z-2634-2011 ยท MQV Filler, Bone Void, Calcium Compound
RTI Biologics, Inc.
***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.
| Date | Jun 23, 2011 (initiated Apr 9, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 26 units |
| Distribution | Domestic Distribution--TN only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043420 | OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE Regeneration Technologies, Inc., Feb 10, 2005 |