BEUDAMED
    FDA Recall Terminated

    VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.

    Recall: Z-2377-2008 · Initiated July 2, 2008

    Recall

    Recall Number
    Z-2377-2008
    Event Number
    49021
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 2, 2008
    Posted
    September 18, 2008
    Terminated
    January 7, 2010
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.

    Reason

    Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.

    Action

    Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence.

    Distribution

    Nationwide Distribution --- including states of AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC.

    Quantity

    16 units.