BEUDAMED
    FDA Recall Terminated

    Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024. The device is intended to be used as a staple line buttress

    Recall: Z-0274-2012 · Initiated October 26, 2011

    Recall

    Recall Number
    Z-0274-2012
    Event Number
    60328
    Firm
    Synovis Surgical Inovation Div. of
    FEI Number
    2183620
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 26, 2011
    Posted
    November 23, 2011
    Terminated
    April 24, 2012
    Address
    2575 University Ave W, Saint Paul, MN, 55114-1073

    Description

    Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024. The device is intended to be used as a staple line buttress

    Reason

    Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.

    Action

    Synovis Surgical Inovation sent a "Recall Notification" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.

    Distribution

    Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.

    Quantity

    132 units