BEUDAMED
    FDA Recall Terminated

    Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.

    Recall: Z-1418-2009 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-1418-2009
    Event Number
    51994
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 8, 2009
    Posted
    May 26, 2009
    Terminated
    April 26, 2010
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.

    Reason

    Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.

    Action

    An "URGENT: Device Recall" letter dated May 11, 2009 was issued to consignees. Consignees were informed that Stryker service representatives will visit each location to affix a caution label identifying the pinch point on each headrest. Additionally, consignees will be provided with an updated surgical table user manual. Direct questions to Stryker Communications Corporation by calling 972-410-7100.

    Distribution

    Nationwide Distribution and Canada.

    Quantity

    230 headrests.