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U.S. Department of Health and Human Services

Class 2 Device Recall OSTEOFIL DBM Paste, 5cc

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 Class 2 Recall
OSTEOFIL DBM Paste, 5cc
see related information
Date Posted June 23, 2011
Recall Status1 Terminated on July 24, 2012
Recall Number Z-2634-2011
Recall Event ID 58887
Premarket Notification
510(K) Number
K043420 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
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.
Code Information 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.
Recalling Firm/
Manufacturer
RTI Biologics, Inc.
11621 Research Cir
Alachua, Florida 32615-6825
For Additional Information Contact Audra McConnell
386-418-8888 Ext. 4806
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = REGENERATION TECHNOLOGIES, INC.
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