BEUDAMED
    FDA Recall Terminated

    Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138

    Recall: Z-1107-2008 · Initiated December 7, 2007

    Recall

    Recall Number
    Z-1107-2008
    Event Number
    46350
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 7, 2007
    Posted
    April 2, 2008
    Terminated
    December 29, 2008
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138

    Reason

    Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.

    Action

    On January 9, 2008, sales representatives were notified via telephone. All consignees were mailed an Urgent: Device Removal notice, dated January 10, 2008. The firm requested that any affected inventory in stock be quarantined and returned to Stryker Endoscopy for destruction. A response form with return postage was included with notification mailed to all consignees.

    Distribution

    Worldwide Distribution - including USA states of South Carolina, Oregon, Michigan, Nebraska, Maryland, California, New Mexico, Ohio, Texas, West Virginia, Massachusetts, and Florida and countries of Canada, Mexico, Hong Kong, Argentina, Brazil, France, Germany, Greece, Spain, India, Italy, Columbia, Switzerland, Poland, Sweden, Australia, and Netherlands.

    Quantity

    142 sliders were distributed.