| Class 2 Device Recall OSTEOFIL DBM Paste, 5cc | |
Date Initiated by Firm | April 09, 2011 |
Date Posted | June 23, 2011 |
Recall Status1 |
Terminated 3 on July 24, 2012 |
Recall Number | Z-2634-2011 |
Recall Event ID |
58887 |
510(K)Number | K043420 |
Product Classification |
Filler,bone void, calcium compound - Product Code MQV
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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 FL 32615-6825
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MQV
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