BEUDAMED
    FDA Enforcement Class II Terminated

    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 Porcine DBM product line is used as a bone void filler.

    Recall: Z-0652-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0652-2013
    Event ID
    63226
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Surgical Tissue Network, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    January 16, 2013
    Initiation Date
    March 14, 2012
    Classification Date
    January 7, 2013
    Termination Date
    December 2, 2014
    Address
    7022 TPC Dr Ste 400, Orlando, FL, 32822-5140, United States

    Description

    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 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.

    Code Info

    Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056

    Distribution

    Worldwide Distribution including Turkey, Greece, & Mexico.

    Quantity

    208 units