BEUDAMED
    FDA Recall Terminated

    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip

    Recall: Z-0964-2007 · Initiated March 16, 2007

    Recall

    Recall Number
    Z-0964-2007
    Event Number
    37671
    Firm
    Synovis Surgical Inovation Div. of
    FEI Number
    2183620
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2007
    Posted
    June 15, 2007
    Terminated
    February 24, 2008
    Address
    2575 University Ave W, Saint Paul, MN, 55114-1073

    Description

    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip

    Reason

    Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.

    Action

    Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.

    Distribution

    Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI

    Quantity

    114