BEUDAMED
    FDA Recall Terminated

    Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table

    Recall: Z-1899-2009 · Initiated November 13, 2008

    Recall

    Recall Number
    Z-1899-2009
    Event Number
    52712
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 13, 2008
    Posted
    August 26, 2009
    Terminated
    August 28, 2009
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table

    Reason

    Surgical tables were produced using an unapproved tilt frame bushing.

    Action

    Stryker Communications issued an "Urgent: Medical Device Recall" notice dated November 13, 2008 informing Consignees of the affected product. The firm intends to contact each facility to coordinate service by a trained representative. For further information, contact Stryker at 1-972-410-7100.

    Distribution

    Worldwide Distribution -- United States (OR, IL, WA, CA, AR, TX, UT, SC and GA) and Canada.

    Quantity

    31