BEUDAMED
    FDA Recall Terminated

    Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.

    Recall: Z-1105-2007 · Initiated October 12, 2004

    Recall

    Recall Number
    Z-1105-2007
    Event Number
    37614
    Firm
    Smith & Nephew, Inc Endoscopy Division
    FEI Number
    1643264
    Product Code
    DWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2004
    Posted
    August 2, 2007
    Terminated
    August 2, 2007
    Address
    76 S. Meridian Ave, Oklahoma City, OK, 73107-6512

    Description

    Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.

    Reason

    Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.

    Action

    Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.

    Distribution

    Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.

    Quantity

    274 units.