BEUDAMED
    FDA Recall Terminated

    Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC

    Recall: Z-2465-2010 · Initiated June 22, 2010

    Recall

    Recall Number
    Z-2465-2010
    Event Number
    56179
    Firm
    Transenterix, INC
    FEI Number
    3007593944
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2010
    Posted
    September 22, 2010
    Terminated
    January 31, 2011
    Address
    3908 Patriot Dr, Ste 170, Durham, NC, 27703-8226

    Description

    Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC

    Reason

    The hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.

    Action

    TransEnterix issued a "Field Action" letter dated June 22, 2010 to consignees, identifying the affected product and actions to be taken by the customer. Customers were instructed to return the product to TransEnterix, Inc. using the address label and return information provided. The firm will replace the product at no charge. TransEnterix Customer Care can be contacted at 1-888-879-4111.

    Distribution

    Nationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX.

    Quantity

    46 boxes (6 units per box)