Date Initiated by Firm | March 14, 2012 |
Date Posted | January 07, 2013 |
Recall Status1 |
Terminated 3 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 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 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 | 160 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.
|