BEUDAMED
    FDA Recall Terminated

    Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303

    Recall: Z-1002-03 · Initiated May 23, 2003

    Recall

    Recall Number
    Z-1002-03
    Event Number
    26449
    Firm
    Coapt Systems, Inc.
    Product Code
    ---
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2003
    Posted
    July 15, 2003
    Terminated
    September 23, 2003
    Address
    1820 Embarcadero Rd., Palo Alto, CA, 94303

    Description

    Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303

    Reason

    During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.

    Action

    On 5/19/03, the firm issued letters via overnight express to all its consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    These products were distributed nationally to 107 consignees and internationally to 2 consignees via distributors and directly to physicians and/or medical facilities. The total number of devices distributed subject to the removal by lot numbers: lot 00045: 19 units; lot 00085: 94 units; and lot 00092: 160 units. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and/or medical facilities who received the recalled products. There is no known U. S. Government or Canadian distribution.

    Quantity

    275 units