BEUDAMED
    FDA Recall Terminated

    PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis Surgical Innovations. Intended to be used as a staple line buttress.

    Recall: Z-2447-2010 · Initiated June 30, 2010

    Recall

    Recall Number
    Z-2447-2010
    Event Number
    56327
    Firm
    Synovis Surgical Inovation Div. of
    FEI Number
    2183620
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 30, 2010
    Posted
    September 21, 2010
    Terminated
    December 17, 2011
    Address
    2575 University Ave W, Saint Paul, MN, 55114-1073

    Description

    PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis Surgical Innovations. Intended to be used as a staple line buttress.

    Reason

    Synovis Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement (PSD-V) products. Internal investigation have shown there is a potential for small defects in the PSD gel tube pouch which may compromise the sterility of the outside of t

    Action

    Consignees were sent on 6/30/10 a Recall Notification letter dated June 30, 2010. The letter was addressed to "Risk Manager". The letter described the problem and product involved. They listed both the device and gel lot numbers since it is possible that some hospitals have separated the pouched gel tubes from the PSD/PSDV products. They advised consignees to quarantine the affected lots and to complete and fax the attached "Product Return/Replacement" form to Synovis Surgical Innovations.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL,IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI and countries of AUSTRALIA, GERMANY, GREECE, HONG KONG, NETHERLANDS, PUERTO RICO, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    3,989 gel tubes and 1,395 PSD & PSDV devices.