BEUDAMED
    FDA Recall Terminated

    SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.

    Recall: Z-0794-2013 · Initiated January 8, 2013

    Recall

    Recall Number
    Z-0794-2013
    Event Number
    64069
    Firm
    Allergen Medical
    FEI Number
    3008374097
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 8, 2013
    Posted
    February 7, 2013
    Terminated
    July 29, 2013
    Address
    200 Boston Avenue, Medford, MA, 02155

    Description

    SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.

    Reason

    Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured

    Action

    Allergan sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers are requested to quarantine and return any unused devices in inventory . In addition, customers are asked to complete and return the acknowledgement form. Customers with questions should contact Allergan at 781-658-2800, Mon- Fri, 9 a.m. to 5 p.m. EST.

    Distribution

    Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.

    Quantity

    225 units (US) and 81 (Outside US)