BEUDAMED
    FDA Recall Terminated

    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915

    Recall: Z-0355-2008 · Initiated September 27, 2007

    Recall

    Recall Number
    Z-0355-2008
    Event Number
    44963
    Firm
    Axya Medical
    FEI Number
    3000718467
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    September 27, 2007
    Posted
    December 8, 2007
    Terminated
    June 21, 2012
    Address
    100 Cummings Ctr, Ste 444c, Beverly, MA, 01915-6132

    Description

    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915

    Reason

    Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging

    Action

    Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.

    Distribution

    Nationwide

    Quantity

    361 units