BEUDAMED
    FDA Recall Terminated

    Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. Manufactured by Stryker Endoscopy Puerto Rico

    Recall: Z-0868-2009 · Initiated December 1, 2008

    Recall

    Recall Number
    Z-0868-2009
    Event Number
    50525
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    December 1, 2008
    Posted
    January 16, 2009
    Terminated
    January 10, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. Manufactured by Stryker Endoscopy Puerto Rico

    Reason

    Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.

    Action

    Recall initiated 12/01/2008, Sales representatives were notified via telephone and e-mail. Product advisories entitled ""Urgent: Device Removal" and dated December 1, 2008, were sent to all consignees. All unused product is to be returned to the firm. For further information, please contact Stryker Endoscopy by telephone at 408-754-2124.

    Distribution

    Worldwide Distribution --- including USA and countries of Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK.

    Quantity

    4,194 boxes (24,750 units)