Recall Z-0651-2013 · MQV Filler, Bone Void, Calcium Compound

Surgical Tissue Network, Inc.

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

Date	Jan 7, 2013 (initiated Mar 14, 2012)
Status	Terminated
Reason	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.
Root cause	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
Quantity	25 units
Distribution	Worldwide Distribution including Turkey, Greece, & Mexico.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.