The Recall Desk

FDA (Devices) recall action 63226

Surgical Tissue Network, Inc. recalled 3 products on 2013-01-16

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-01-16
Critical
0
Units
393

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the 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: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porc
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network, Inc. recalled UltraFill DBM Putty-Porcine 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 Por
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the 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: 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 DB
    Category
    Distribution
    0 states