Recall Z-0651-2013— Surgical Tissue Network, Inc.
Class II · Terminated
Class II FDA medical device recall by Surgical Tissue Network, Inc., initiated 2012-03-14, terminated 2014-12-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Surgical Tissue Network, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-03-14
- Terminated
- 2014-12-02
- Firm location
- Orlando, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.