| Date Posted |
January 07, 2013 |
| Recall Number |
Z-0651-2013 |
| Product |
Ultrafill DBM labeled in part: "***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***"
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, Florida 32822-5140 |
| For Additional Information Contact |
Gene S. Elliot
407-380-2424 Ext. 230
|
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.
|
| 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. |
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