FDA-Device2013-01-16Class II
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
Surgical Tissue Network, Inc.
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.
Sold states
Worldwide Distribution including Turkey, Greece, & Mexico.
Affected count
25 units
Manufactured in
7022 TPC Dr Ste 400, Orlando, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0651-2013Don't want to check this manually?
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