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Surgical Tissue Network, Inc. recalls UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT
Recalled January 16, 2013 · FDA recall Z-0653-2013 · Surgical Tissue Network
Hazard
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 Class II
Units
160 units
Sold at
Worldwide Distribution including Turkey, Greece, & Mexico.
Description
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.
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.
Manufacturer(s)
Surgical Tissue Network, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →