||January 07, 2013
||Terminated on December 02, 2014
|Recall Event ID
Filler, bone void, calcium compound -
||Ultrafill DBM labeled in part: &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;***TISSUENET***Sterilized by T10^6 (r)***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***&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;
TissueNet's Porcine DBM product line is used as a bone void filler
||Product Code: RT53001
Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and
TN29041-11-0083 through TN29041-11-0119
Surgical Tissue Network, Inc.
7022 TPC Dr Ste 400
407-380-2424 Ext. 221
|For Additional Information Contact
||Gene S. Elliot
407-380-2424 Ext. 230
|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.
||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
||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.