FDAFDA · Food and drugs·Recall number Z-0651-2013
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
Published January 16, 2013 · Recall initiated: March 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Surgical Tissue Network, Inc.
- Distributor
- Worldwide Distribution including Turkey, Greece, & Mexico.
- Lot
- Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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