Home / Recalls / Surgical Tissue Network, Inc. / Z-0651-2013

Z-0651-2013 Class II Terminated

Recalled by Surgical Tissue Network, Inc. — Orlando, FL

Recall Details

Product Type: Devices
Report Date: January 16, 2013
Initiation Date: March 14, 2012
Termination Date: December 2, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25 units

Product Description

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

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.

Distribution Pattern

Worldwide Distribution including Turkey, Greece, & Mexico.

Code Information

Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119