BEUDAMED
    FDA Recall Terminated

    ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Recall: Z-0089-04 · Initiated August 21, 2002

    Recall

    Recall Number
    Z-0089-04
    Event Number
    27468
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 21, 2002
    Posted
    November 6, 2003
    Terminated
    December 11, 2003
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Reason

    Complaints were reported of difficulty in stent deployment.

    Action

    Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement.

    Distribution

    The device was distributed nationwide, Ireland and Jordan.

    Quantity

    155 units