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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrafill DBM

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  Class 2 Device Recall Ultrafill DBM see related information
Date Initiated by Firm March 14, 2012
Date Posting Updated January 07, 2013
Recall Status1 Terminated 3 on December 02, 2014
Recall Number Z-0651-2013
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 Description: UltraFill DBM Size: 1cc Product Code: RT53001 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: RT53001, Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and, TN29041-11-0083 through TN29041-11-0119
Recalling Firm/
Manufacturer
Surgical Tissue Network, Inc.
7022 TPC Dr Ste 400
Orlando FL 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
Employee error
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 25 units
Distribution Worldwide Distribution including Turkey, Greece, & Mexico.
Total Product Life Cycle TPLC Device Report

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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