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U.S. Department of Health and Human Services

Class 2 Device Recall UltraFill DBM

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 Class 2 Recall
UltraFill DBM
see related information
Date Posted January 07, 2013
Recall Status1 Terminated on December 02, 2014
Recall Number Z-0653-2013
Recall Event ID 63226
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product UltraFill DBM labeled in part: "***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 10cc***Product Code: RT53010***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***" TissueNet's Porcine DBM product line is used as a bone void filler.
Code Information Product Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
Recalling Firm/
Manufacturer
Surgical Tissue Network, Inc.
7022 TPC Dr Ste 400
Orlando, Florida 32822-5140
For Additional Information Contact Gene S. Elliot
407-380-2424 Ext. 230
Manufacturer Reason
for Recall
Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Surgical Tissue Network sent a Notification of Voluntary Tissue Recall dated March 22, 2012, to all affected customers. The firm issued an additional notification letter on August 30, 2012. The letter identified the product, the problem, and action to be taken by the customer. Consignees were asked to return all listed products that remain in inventory. If the product was further distributed, they were asked to forward the recall information to their customers. Customers were instructed to contact TissueNet's Customer Service Department at 800-465-8800 x283 to coordinate return/replacement of the affected product. Customers with questions were instructed to call 800-465-8800 x230. For questions regarding this recall call 407-380-2424.
Quantity in Commerce 160 units
Distribution Worldwide Distribution including Turkey, Greece, & Mexico.
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.
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