BEUDAMED
    FDA Recall Terminated

    Spiral Z Expandable Metal Biliary Stent

    Recall: Z-1179-03 · Initiated January 8, 2002

    Recall

    Recall Number
    Z-1179-03
    Event Number
    26966
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2002
    Posted
    August 26, 2003
    Terminated
    March 21, 2005
    Address
    4900 Bethania Station Rd, &, Winston-Salem, NC, 27105

    Description

    Spiral Z Expandable Metal Biliary Stent

    Reason

    The inner catheter of the introducer system may break after stent deployment.

    Action

    Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.

    Distribution

    The product was distributed to hospitals located nationwide and worldwide.

    Quantity

    23 units