BEUDAMED
    FDA Recall Terminated

    Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 2575 University Ave. W., St. Paul, MN 55114-1024 USA.

    Recall: Z-0764-06 · Initiated November 1, 2005

    Recall

    Recall Number
    Z-0764-06
    Event Number
    34052
    Firm
    Synovis Surgical Inovation Div. of
    FEI Number
    2183620
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2005
    Posted
    April 13, 2006
    Terminated
    February 3, 2007
    Address
    2575 University Ave W, Saint Paul, MN, 55114-1073

    Description

    Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 2575 University Ave. W., St. Paul, MN 55114-1024 USA.

    Reason

    The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.

    Action

    An initial phone call was placed to expedite return and replacement of product. A follow-up letter was sent. The initial phone calls to customers began on November 1, 2005.

    Distribution

    Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and VA

    Quantity

    4,950